Damian McNamara

ORLANDO – Lasers can effectively target and treat several well-known pediatric skin conditions and, thanks to advances in technology, potentially treat more in the near future, according to Dr. Jan Izakovic.

The right laser in skilled hands can improve port wine stains, superficial hemangiomas, and nevi, he said at the annual meeting of the Florida Society of Dermatologic Surgeons. Children with vitiligo, likewise, can experience repigmentation with appropriate laser treatment, based on evidence in the literature and personal experience, he added.

In contrast, the use of lasers for striae, café au lait spots, and other potential indications is supported only by smaller case report–type studies, said Dr. Izakovic, codirector of pediatric dermatology at the University of Miami.

Port Wine Stains

The pulsed dye laser (PDL) is a frequent player in Dr. Izakovic’s armamentarium. When a child presents with a port wine stain, for example, he said he treats them with 585-nm or 595-nm PDLs. Nd:YAG and intense pulsed light (IPL), as well as a combination approach, are other options.

"I usually do a small test area first, and eventually increase the energy in small increments if there is no or too little effect," Dr. Izakovic said. Treatments should be scheduled at 4- to 6-week intervals. The total number of sessions will vary. "You can have great success after one or two treatments, but I wouldn’t tell parents that up front," he said.

About 70%-80% lightening of the port wine stain is realistic. Ultimately, success depends on the color, site, and thickness of the lesion. "The whiter the skin and the redder the port wine stain, the better your outcome will be," Dr. Izakovic said.

"Pain is usually minimal and momentary," but counsel patients on possible effects so they know what to expect, he advised. Purpura associated with PDL treatment generally resolves in 10-12 days, for example. Also, "you can expect to see the white dots fully formed 3-4 weeks post treatment. Tell patients you will address the leftovers at the next session," Dr. Izakovic said.

A comparison study found lightening of port wine stains to be similar with either PDL or IPL (Br. J. Dermatol. 2009;160:359-64). However, PDL was associated with better overall efficacy and was preferred by patients.

IPL has the advantage of only rarely causing purpura, Dr. Izakovic said.

Although he has not used combination therapy, Dr. Izakovic said better outcomes might be possible when PDL treatment is combined with photodynamic therapy, imiquimod, or rapamycin.

Hemangioma Treatment

PDL 585-nm or 595-nm devices can also treat superficial hemangiomas or ulcerated hemangiomas, or improve residual erythema or telangiectasia following involution of a hemangioma, he said. Although some physicians might be reluctant to treat a superficial eyelid hemangioma with PDL, there is some support for this as well in the literature (Dermatol. Surg. 2010;36:590-7).

Lasers can be used in a combination approach with other therapies such as oral propranolol or steroids, Dr. Izakovic said. "[With lasers] you are helping with the superficial part of it." PDL energy at the highest setting penetrates to a maximum of 1.5 mm.

Immediate results with a laser can be beneficial, which provides great relief for parents. "I tell them the goal is to stop the growth, stop the darkening, and stimulate the involution, " he said.

Children With Nevi

Lasers also can treat nevi of Ota, Dr. Izakovic said, but there is some variability in outcome; however, satisfying results can be achieved.

The issue surrounds complete ablation of a regular nevus with laser energy. He said he prefers to reserve laser treatment for children who first had a biopsy to rule out malignancy. Another option is to remove the nevus surgically and test the sample for any relevant pathology. "Always check what you remove histologically when you remove nevi," he said.

Several Q-switched lasers, such as a ruby 694 nm, an alexandrite 755 nm, and an Nd:YAG 1,064 nm, are appropriate for nevi treatment. Remember that anesthesia might be indicated because treatment with a Q-switched laser can be painful, he said.

Pediatric Vitiligo

Children with vitiligo can likewise see improvement following laser treatment, Dr. Izakovic said. Among the newer options is the use of an excimer laser 308 nm by itself or in combination with topical therapies. The use of this device is increasing for the treatment of vitiligo, especially on isolated small areas of the face, neck, or head, he said.

"There are some good responses after a couple of treatments. You can see signs of repigmentation," he noted.

Other Uses

Rarer instances include PDL 585-nm treatment of striae. "This only treats the erythematous part and it’s not an overwhelming effect," Dr. Izakovic said. Café au lait spot lightening is another marginal indication for lasers that is not yet fully supported in the literature.

There have been case reports of laser treatment of molluscum contagiosum, atopic dermatitis, and lichen sclerosus et atrophicus. Laser treatment for such marginal indications, where there are other well-established treatment options, remains to be supported by more rigorous research, he said.

Dr. Izakovic said that he had no relevant financial disclosures.

ORLANDO – Lasers can effectively target and treat several well-known pediatric skin conditions and, thanks to advances in technology, potentially treat more in the near future, according to Dr. Jan Izakovic.

The right laser in skilled hands can improve port wine stains, superficial hemangiomas, and nevi, he said at the annual meeting of the Florida Society of Dermatologic Surgeons. Children with vitiligo, likewise, can experience repigmentation with appropriate laser treatment, based on evidence in the literature and personal experience, he added.

In contrast, the use of lasers for striae, café au lait spots, and other potential indications is supported only by smaller case report–type studies, said Dr. Izakovic, codirector of pediatric dermatology at the University of Miami.

Port Wine Stains

The pulsed dye laser (PDL) is a frequent player in Dr. Izakovic’s armamentarium. When a child presents with a port wine stain, for example, he said he treats them with 585-nm or 595-nm PDLs. Nd:YAG and intense pulsed light (IPL), as well as a combination approach, are other options.

"I usually do a small test area first, and eventually increase the energy in small increments if there is no or too little effect," Dr. Izakovic said. Treatments should be scheduled at 4- to 6-week intervals. The total number of sessions will vary. "You can have great success after one or two treatments, but I wouldn’t tell parents that up front," he said.

About 70%-80% lightening of the port wine stain is realistic. Ultimately, success depends on the color, site, and thickness of the lesion. "The whiter the skin and the redder the port wine stain, the better your outcome will be," Dr. Izakovic said.

"Pain is usually minimal and momentary," but counsel patients on possible effects so they know what to expect, he advised. Purpura associated with PDL treatment generally resolves in 10-12 days, for example. Also, "you can expect to see the white dots fully formed 3-4 weeks post treatment. Tell patients you will address the leftovers at the next session," Dr. Izakovic said.

A comparison study found lightening of port wine stains to be similar with either PDL or IPL (Br. J. Dermatol. 2009;160:359-64). However, PDL was associated with better overall efficacy and was preferred by patients.

IPL has the advantage of only rarely causing purpura, Dr. Izakovic said.

Although he has not used combination therapy, Dr. Izakovic said better outcomes might be possible when PDL treatment is combined with photodynamic therapy, imiquimod, or rapamycin.

Hemangioma Treatment

PDL 585-nm or 595-nm devices can also treat superficial hemangiomas or ulcerated hemangiomas, or improve residual erythema or telangiectasia following involution of a hemangioma, he said. Although some physicians might be reluctant to treat a superficial eyelid hemangioma with PDL, there is some support for this as well in the literature (Dermatol. Surg. 2010;36:590-7).

Lasers can be used in a combination approach with other therapies such as oral propranolol or steroids, Dr. Izakovic said. "[With lasers] you are helping with the superficial part of it." PDL energy at the highest setting penetrates to a maximum of 1.5 mm.

Immediate results with a laser can be beneficial, which provides great relief for parents. "I tell them the goal is to stop the growth, stop the darkening, and stimulate the involution, " he said.

Children With Nevi

Lasers also can treat nevi of Ota, Dr. Izakovic said, but there is some variability in outcome; however, satisfying results can be achieved.

The issue surrounds complete ablation of a regular nevus with laser energy. He said he prefers to reserve laser treatment for children who first had a biopsy to rule out malignancy. Another option is to remove the nevus surgically and test the sample for any relevant pathology. "Always check what you remove histologically when you remove nevi," he said.

Several Q-switched lasers, such as a ruby 694 nm, an alexandrite 755 nm, and an Nd:YAG 1,064 nm, are appropriate for nevi treatment. Remember that anesthesia might be indicated because treatment with a Q-switched laser can be painful, he said.

Pediatric Vitiligo

Children with vitiligo can likewise see improvement following laser treatment, Dr. Izakovic said. Among the newer options is the use of an excimer laser 308 nm by itself or in combination with topical therapies. The use of this device is increasing for the treatment of vitiligo, especially on isolated small areas of the face, neck, or head, he said.

"There are some good responses after a couple of treatments. You can see signs of repigmentation," he noted.

Other Uses

Rarer instances include PDL 585-nm treatment of striae. "This only treats the erythematous part and it’s not an overwhelming effect," Dr. Izakovic said. Café au lait spot lightening is another marginal indication for lasers that is not yet fully supported in the literature.

There have been case reports of laser treatment of molluscum contagiosum, atopic dermatitis, and lichen sclerosus et atrophicus. Laser treatment for such marginal indications, where there are other well-established treatment options, remains to be supported by more rigorous research, he said.

Dr. Izakovic said that he had no relevant financial disclosures.

ORLANDO – Lasers can effectively target and treat several well-known pediatric skin conditions and, thanks to advances in technology, potentially treat more in the near future, according to Dr. Jan Izakovic.

The right laser in skilled hands can improve port wine stains, superficial hemangiomas, and nevi, he said at the annual meeting of the Florida Society of Dermatologic Surgeons. Children with vitiligo, likewise, can experience repigmentation with appropriate laser treatment, based on evidence in the literature and personal experience, he added.

In contrast, the use of lasers for striae, café au lait spots, and other potential indications is supported only by smaller case report–type studies, said Dr. Izakovic, codirector of pediatric dermatology at the University of Miami.

Port Wine Stains

The pulsed dye laser (PDL) is a frequent player in Dr. Izakovic’s armamentarium. When a child presents with a port wine stain, for example, he said he treats them with 585-nm or 595-nm PDLs. Nd:YAG and intense pulsed light (IPL), as well as a combination approach, are other options.

"I usually do a small test area first, and eventually increase the energy in small increments if there is no or too little effect," Dr. Izakovic said. Treatments should be scheduled at 4- to 6-week intervals. The total number of sessions will vary. "You can have great success after one or two treatments, but I wouldn’t tell parents that up front," he said.

About 70%-80% lightening of the port wine stain is realistic. Ultimately, success depends on the color, site, and thickness of the lesion. "The whiter the skin and the redder the port wine stain, the better your outcome will be," Dr. Izakovic said.

"Pain is usually minimal and momentary," but counsel patients on possible effects so they know what to expect, he advised. Purpura associated with PDL treatment generally resolves in 10-12 days, for example. Also, "you can expect to see the white dots fully formed 3-4 weeks post treatment. Tell patients you will address the leftovers at the next session," Dr. Izakovic said.

A comparison study found lightening of port wine stains to be similar with either PDL or IPL (Br. J. Dermatol. 2009;160:359-64). However, PDL was associated with better overall efficacy and was preferred by patients.

IPL has the advantage of only rarely causing purpura, Dr. Izakovic said.

Although he has not used combination therapy, Dr. Izakovic said better outcomes might be possible when PDL treatment is combined with photodynamic therapy, imiquimod, or rapamycin.

Hemangioma Treatment

PDL 585-nm or 595-nm devices can also treat superficial hemangiomas or ulcerated hemangiomas, or improve residual erythema or telangiectasia following involution of a hemangioma, he said. Although some physicians might be reluctant to treat a superficial eyelid hemangioma with PDL, there is some support for this as well in the literature (Dermatol. Surg. 2010;36:590-7).

Lasers can be used in a combination approach with other therapies such as oral propranolol or steroids, Dr. Izakovic said. "[With lasers] you are helping with the superficial part of it." PDL energy at the highest setting penetrates to a maximum of 1.5 mm.

Immediate results with a laser can be beneficial, which provides great relief for parents. "I tell them the goal is to stop the growth, stop the darkening, and stimulate the involution, " he said.

Children With Nevi

Lasers also can treat nevi of Ota, Dr. Izakovic said, but there is some variability in outcome; however, satisfying results can be achieved.

The issue surrounds complete ablation of a regular nevus with laser energy. He said he prefers to reserve laser treatment for children who first had a biopsy to rule out malignancy. Another option is to remove the nevus surgically and test the sample for any relevant pathology. "Always check what you remove histologically when you remove nevi," he said.

Several Q-switched lasers, such as a ruby 694 nm, an alexandrite 755 nm, and an Nd:YAG 1,064 nm, are appropriate for nevi treatment. Remember that anesthesia might be indicated because treatment with a Q-switched laser can be painful, he said.

Pediatric Vitiligo

Children with vitiligo can likewise see improvement following laser treatment, Dr. Izakovic said. Among the newer options is the use of an excimer laser 308 nm by itself or in combination with topical therapies. The use of this device is increasing for the treatment of vitiligo, especially on isolated small areas of the face, neck, or head, he said.

"There are some good responses after a couple of treatments. You can see signs of repigmentation," he noted.

Other Uses

Rarer instances include PDL 585-nm treatment of striae. "This only treats the erythematous part and it’s not an overwhelming effect," Dr. Izakovic said. Café au lait spot lightening is another marginal indication for lasers that is not yet fully supported in the literature.

There have been case reports of laser treatment of molluscum contagiosum, atopic dermatitis, and lichen sclerosus et atrophicus. Laser treatment for such marginal indications, where there are other well-established treatment options, remains to be supported by more rigorous research, he said.

Dr. Izakovic said that he had no relevant financial disclosures.

ORLANDO – One number keeps coming up with the new autologous fibroblast biologic product that enhances a patient’s nasolabial wrinkles: three.

"There are a lot of threes: three biopsies 3 mm in size, a 3 month’s wait, and three treatment sessions," Dr. Robert Weiss said at the annual meeting of the Florida Society of Dermatology Surgeons.

The Food and Drug Administration cleared the marketing of Fibrocell Science’s azficel-T (LaVív) in June 2011, and the product is now reaching the market. "It’s very exciting to be right at the launch of this," said Dr .Weiss, a dermatologist in private practice in Hunt Valley, Md., and with the dermatology department at Johns Hopkins University, Baltimore. "I’ve been working on this for close to a decade, so it was a personal triumph to see this finally cleared by the FDA."

The FDA based its clearance on two identically designed, multicenter, double-blind, vehicle-controlled studies. A total of 421 patients with moderate to severe nasolabial fold wrinkles were assessed, with 210 being randomized to azficel-T and 211 to vehicle injections. The average age was 55 years, and 90% were women.

A 2-point improvement in the appearance of the nasolabial fold wrinkles was the primary outcome. Physicians at the study sites who were not injectors blindly rated results.

At the 6-month follow-up, doctors observed the 2-point improvement in 33% of the azficel-T group, compared with 7% of controls in the first study. In the second study, 19% of the azficel-T group had at least a 2-point improvement, compared with 7% of controls. These differences were on the borderline of statistical significance, Dr. Weiss said.

"The FDA was convinced that this was effective. We were certainly very convinced by what we observed with the patients," Dr. Weiss said.

Patient reported outcomes were more statistically significant, with 57% reporting a 2-point improvement, compared with 30% in the vehicle group in an intent-to-treat analysis of the first study. In the second study, 45% of the treated patients reported this outcome, compared with 18% of the vehicle group.

The most common adverse effects were injection site reactions lasting approximately 2 hours, Dr. Weiss said. These events included erythema, bruising, and swelling. Facial or eyelid edema, hypersensitivity or decreased skin sensation at the injection site, and postprocedural discomfort were among the adverse events reported by 1% of patients or fewer.

"One of the first questions patients ask me is: ‘How are you going to make sure I’m getting my own cells?’ " Dr. Weiss explained there are strict controls. Each patient is assigned a lot number. Vials for injection are labeled with each patient’s initials, date of birth, and a unique identification number. "All the critical steps are verified twice."

The treatment protocol involves extraction, purification, culturing, and injection. Dr. Weiss said he injects 1 cc to 2 cc of lidocaine in the postauricular area before taking the biopsies. The tissue is sent to Fibrocell for purification and culturing of the fibroblasts.

After 3 months, a vial containing 15 million to 20 million fibroblasts is shipped back to arrive just prior to the patient appointment. "Advise your patients that advance notice of at least 2 business days is required to reschedule treatment. By the FDA guidelines, you cannot inject the cells the next day because the viability count goes down." Treatment at 3- to 6-week intervals is recommended.

Because the product is a biologic, the FDA requires physician certification prior to use of azficel-T. "If you are interested in offering this to your patients, the company will train your staff. There are webinars," Dr. Weiss said. Staff training reinforces proper packing, handling, and shipping.

The product has to be handled gingerly and injected superficially in the papillary dermis, he said. "This is for superficial rhytids; this is not a deep volume filler." The needle will be visible under the skin if you are injecting in the right plane.

Resuspend the cells by inverting the vial slowly a few times. Be careful putting the vial on the tray because it can fall over. Apply light pressure to the plunger and inject slowly along the wrinkle line.

Instruct the patient not to wash the site for 24 hours and not to scrub, rub, massage, or apply any pressure for 72 hours. An NSAID can be taken for pain.

Also, instruct patients to call if they experience any adverse reactions. Fibrocell plans to launch a patient registry in July 2012 that will track hypersensitivity reactions.

Dr. Weiss participated in one of the clinical trials as early as 2003. "What we’ve noted on long-term follow-up is that patients maintain this improvement, often for many, many years, which is interesting."

"I’ve seen some phenomenal results, particularly in studies of acne scars, which is another potential application the company is applying for," he added.

Dr. Weiss has been an investigator for Fibrocell Science, which sponsored his presentation.

ORLANDO – One number keeps coming up with the new autologous fibroblast biologic product that enhances a patient’s nasolabial wrinkles: three.

"There are a lot of threes: three biopsies 3 mm in size, a 3 month’s wait, and three treatment sessions," Dr. Robert Weiss said at the annual meeting of the Florida Society of Dermatology Surgeons.

The Food and Drug Administration cleared the marketing of Fibrocell Science’s azficel-T (LaVív) in June 2011, and the product is now reaching the market. "It’s very exciting to be right at the launch of this," said Dr .Weiss, a dermatologist in private practice in Hunt Valley, Md., and with the dermatology department at Johns Hopkins University, Baltimore. "I’ve been working on this for close to a decade, so it was a personal triumph to see this finally cleared by the FDA."

The FDA based its clearance on two identically designed, multicenter, double-blind, vehicle-controlled studies. A total of 421 patients with moderate to severe nasolabial fold wrinkles were assessed, with 210 being randomized to azficel-T and 211 to vehicle injections. The average age was 55 years, and 90% were women.

A 2-point improvement in the appearance of the nasolabial fold wrinkles was the primary outcome. Physicians at the study sites who were not injectors blindly rated results.

At the 6-month follow-up, doctors observed the 2-point improvement in 33% of the azficel-T group, compared with 7% of controls in the first study. In the second study, 19% of the azficel-T group had at least a 2-point improvement, compared with 7% of controls. These differences were on the borderline of statistical significance, Dr. Weiss said.

"The FDA was convinced that this was effective. We were certainly very convinced by what we observed with the patients," Dr. Weiss said.

Patient reported outcomes were more statistically significant, with 57% reporting a 2-point improvement, compared with 30% in the vehicle group in an intent-to-treat analysis of the first study. In the second study, 45% of the treated patients reported this outcome, compared with 18% of the vehicle group.

The most common adverse effects were injection site reactions lasting approximately 2 hours, Dr. Weiss said. These events included erythema, bruising, and swelling. Facial or eyelid edema, hypersensitivity or decreased skin sensation at the injection site, and postprocedural discomfort were among the adverse events reported by 1% of patients or fewer.

"One of the first questions patients ask me is: ‘How are you going to make sure I’m getting my own cells?’ " Dr. Weiss explained there are strict controls. Each patient is assigned a lot number. Vials for injection are labeled with each patient’s initials, date of birth, and a unique identification number. "All the critical steps are verified twice."

The treatment protocol involves extraction, purification, culturing, and injection. Dr. Weiss said he injects 1 cc to 2 cc of lidocaine in the postauricular area before taking the biopsies. The tissue is sent to Fibrocell for purification and culturing of the fibroblasts.

After 3 months, a vial containing 15 million to 20 million fibroblasts is shipped back to arrive just prior to the patient appointment. "Advise your patients that advance notice of at least 2 business days is required to reschedule treatment. By the FDA guidelines, you cannot inject the cells the next day because the viability count goes down." Treatment at 3- to 6-week intervals is recommended.

Because the product is a biologic, the FDA requires physician certification prior to use of azficel-T. "If you are interested in offering this to your patients, the company will train your staff. There are webinars," Dr. Weiss said. Staff training reinforces proper packing, handling, and shipping.

The product has to be handled gingerly and injected superficially in the papillary dermis, he said. "This is for superficial rhytids; this is not a deep volume filler." The needle will be visible under the skin if you are injecting in the right plane.

Resuspend the cells by inverting the vial slowly a few times. Be careful putting the vial on the tray because it can fall over. Apply light pressure to the plunger and inject slowly along the wrinkle line.

Instruct the patient not to wash the site for 24 hours and not to scrub, rub, massage, or apply any pressure for 72 hours. An NSAID can be taken for pain.

Also, instruct patients to call if they experience any adverse reactions. Fibrocell plans to launch a patient registry in July 2012 that will track hypersensitivity reactions.

Dr. Weiss participated in one of the clinical trials as early as 2003. "What we’ve noted on long-term follow-up is that patients maintain this improvement, often for many, many years, which is interesting."

"I’ve seen some phenomenal results, particularly in studies of acne scars, which is another potential application the company is applying for," he added.

Dr. Weiss has been an investigator for Fibrocell Science, which sponsored his presentation.

ORLANDO – One number keeps coming up with the new autologous fibroblast biologic product that enhances a patient’s nasolabial wrinkles: three.

"There are a lot of threes: three biopsies 3 mm in size, a 3 month’s wait, and three treatment sessions," Dr. Robert Weiss said at the annual meeting of the Florida Society of Dermatology Surgeons.

The Food and Drug Administration cleared the marketing of Fibrocell Science’s azficel-T (LaVív) in June 2011, and the product is now reaching the market. "It’s very exciting to be right at the launch of this," said Dr .Weiss, a dermatologist in private practice in Hunt Valley, Md., and with the dermatology department at Johns Hopkins University, Baltimore. "I’ve been working on this for close to a decade, so it was a personal triumph to see this finally cleared by the FDA."

The FDA based its clearance on two identically designed, multicenter, double-blind, vehicle-controlled studies. A total of 421 patients with moderate to severe nasolabial fold wrinkles were assessed, with 210 being randomized to azficel-T and 211 to vehicle injections. The average age was 55 years, and 90% were women.

A 2-point improvement in the appearance of the nasolabial fold wrinkles was the primary outcome. Physicians at the study sites who were not injectors blindly rated results.

At the 6-month follow-up, doctors observed the 2-point improvement in 33% of the azficel-T group, compared with 7% of controls in the first study. In the second study, 19% of the azficel-T group had at least a 2-point improvement, compared with 7% of controls. These differences were on the borderline of statistical significance, Dr. Weiss said.

"The FDA was convinced that this was effective. We were certainly very convinced by what we observed with the patients," Dr. Weiss said.

Patient reported outcomes were more statistically significant, with 57% reporting a 2-point improvement, compared with 30% in the vehicle group in an intent-to-treat analysis of the first study. In the second study, 45% of the treated patients reported this outcome, compared with 18% of the vehicle group.

The most common adverse effects were injection site reactions lasting approximately 2 hours, Dr. Weiss said. These events included erythema, bruising, and swelling. Facial or eyelid edema, hypersensitivity or decreased skin sensation at the injection site, and postprocedural discomfort were among the adverse events reported by 1% of patients or fewer.

"One of the first questions patients ask me is: ‘How are you going to make sure I’m getting my own cells?’ " Dr. Weiss explained there are strict controls. Each patient is assigned a lot number. Vials for injection are labeled with each patient’s initials, date of birth, and a unique identification number. "All the critical steps are verified twice."

The treatment protocol involves extraction, purification, culturing, and injection. Dr. Weiss said he injects 1 cc to 2 cc of lidocaine in the postauricular area before taking the biopsies. The tissue is sent to Fibrocell for purification and culturing of the fibroblasts.

After 3 months, a vial containing 15 million to 20 million fibroblasts is shipped back to arrive just prior to the patient appointment. "Advise your patients that advance notice of at least 2 business days is required to reschedule treatment. By the FDA guidelines, you cannot inject the cells the next day because the viability count goes down." Treatment at 3- to 6-week intervals is recommended.

Because the product is a biologic, the FDA requires physician certification prior to use of azficel-T. "If you are interested in offering this to your patients, the company will train your staff. There are webinars," Dr. Weiss said. Staff training reinforces proper packing, handling, and shipping.

The product has to be handled gingerly and injected superficially in the papillary dermis, he said. "This is for superficial rhytids; this is not a deep volume filler." The needle will be visible under the skin if you are injecting in the right plane.

Resuspend the cells by inverting the vial slowly a few times. Be careful putting the vial on the tray because it can fall over. Apply light pressure to the plunger and inject slowly along the wrinkle line.

Instruct the patient not to wash the site for 24 hours and not to scrub, rub, massage, or apply any pressure for 72 hours. An NSAID can be taken for pain.

Also, instruct patients to call if they experience any adverse reactions. Fibrocell plans to launch a patient registry in July 2012 that will track hypersensitivity reactions.

Dr. Weiss participated in one of the clinical trials as early as 2003. "What we’ve noted on long-term follow-up is that patients maintain this improvement, often for many, many years, which is interesting."

"I’ve seen some phenomenal results, particularly in studies of acne scars, which is another potential application the company is applying for," he added.

Dr. Weiss has been an investigator for Fibrocell Science, which sponsored his presentation.

HOLLYWOOD, FLA. – Surgical outcomes of robotic-assisted hysterectomy did not differ significantly for women whether they were nonobese, obese, or morbidly obese, in a study of 442 women classified according to body mass index.

"Our findings reiterate the safety of robotic hysterectomy for the obese and morbidly obese patients," Dr. Taryn Gallo said. "As minimally invasive surgeons, we know every day we are facing bigger and bigger patients. You can’t underestimate the value of being able to offer these women a minimally invasive approach and sending them home the next day."

Approximately 34% of U.S. women are obese with a body mass index (BMI) of 30 kg/m2 or greater, according to the World Health Organization. Obesity and its comorbidities are well-known risk factors that affect surgical outcomes. These challenges are not limited to laparotomy. "With laparoscopy there are also difficulties with the surgery that we are all familiar with," Dr. Gallo said at the AAGL annual meeting.

Difficulty obtaining pneumoperitoneum secondary to preperitoneal fat, difficulty ventilating these women in steep Trendelenburg position, and difficulty gaining adequate exposure during surgery are among the challenges in this patient population, she added.

"In the gynecologic literature, few studies have addressed robotic surgery for the morbidly obese patient," Dr. Gallo said. So she and her colleagues retrospectively studied women who underwent robotic-assisted hysterectomy over a 4-year period in a single surgeon teaching practice. Dr. Masoud Azodi, the senior author and surgeon in this study, is director of the minimally invasive gynecologic surgery (MIGS) fellowship program at Yale University, New Haven.

A total of 58% of the 442 women were obese or morbidly obese, said Dr. Gallo, a gynecologist in private practice in Sebastian, Fla. She was a minimally invasive gynecologic surgery fellow at Bridgeport Hospital/Yale New Haven Health System in Connecticut at the time of the study.

"All BMI groups had similar outcomes," Dr. Gallo said. Median operative times, estimated blood loss, length of stay, and complication rates did not differ significantly among the nonobese women (BMI less than 30 kg/m², median 25 kg/m²); obese women (BMI of 30-39.9 kg/m², median 34 kg/m²); and morbidly obese women (BMI of 40 kg/m² or greater, median 44 kg/m²).

Median operative time for the entire cohort from skin incision to skin closure was 135 minutes. This included time for any concomitant procedures, such as lymphadenectomy or pelvic floor repair, she said. Median operative time by BMI group was similar: 141 minutes for the nonobese group, 135 minutes for the obese women, and 124 minutes for the morbidly obese.

Three patients, one in each BMI group, were converted to laparotomy, for an overall rate of 0.7%.

Median estimated blood loss overall and in each BMI group was 100 mL. Median length of hospital stay of 1 day, likewise, was the same overall and in each group.

The overall complication rate in the study was 12%. This figure includes a major complication rate of 4% (readmissions, reoperations) and a minor complication rate of 8%. "By BMI group, the complications – major, minor, or total – these did not differ," Dr. Gallo said.

Urinary complications affected 11 women (2.6%), including 1% who had bladder injuries recognized and repaired intraoperatively and 1.6% who had ureteral injuries. Two women with ureteral injuries were repaired with stenting, and four others required subsequent ureteral reimplantation, she said.

Bowel injuries occurred in six patients. Four cases were recognized and repaired intraoperatively, and two women required reoperation and bowel resection.

The remainder of the complications in the study occurred less than 1% of the time. One patient, in the nonobese BMI group, had a vaginal cuff dehiscence, for an overall rate of 0.2% in the study.

Patient demographics were similar between groups. For example, the median age was 51 years in the nonobese, 55 years in the obese, and 54 years in the morbidly obese groups. Women underwent hysterectomy for benign and malignant indications, including early endometrial cancer, early cervical cancer, and occult ovarian cancer.

The retrospective design of the study is a limitation, Dr. Gallo said, and no absolute conclusions can be drawn. "Also, our study was not adequately powered. We would have required more than 4,300 patients to detect a difference in operative time between BMI groups with a power of 80%."

She added, "Our study may not be generalizable to other surgeons or other institutions – this was a single surgeon with a high surgical volume and extensive experience in laparoscopic and robotic surgery.

"Despite these limitations, we believe our study offers clinically relevant information pertaining to the growing number of obese patients that will be faced by minimally invasive surgeons," she said.

Assessment of costs associated with robotic-assisted hysterectomy was outside the scope of this study.

Dr. Gallo said the minimally invasive gynecologic fellowship program at Yale has received an educational grant from Intuitive Surgical.

HOLLYWOOD, FLA. – Surgical outcomes of robotic-assisted hysterectomy did not differ significantly for women whether they were nonobese, obese, or morbidly obese, in a study of 442 women classified according to body mass index.

"Our findings reiterate the safety of robotic hysterectomy for the obese and morbidly obese patients," Dr. Taryn Gallo said. "As minimally invasive surgeons, we know every day we are facing bigger and bigger patients. You can’t underestimate the value of being able to offer these women a minimally invasive approach and sending them home the next day."

Approximately 34% of U.S. women are obese with a body mass index (BMI) of 30 kg/m2 or greater, according to the World Health Organization. Obesity and its comorbidities are well-known risk factors that affect surgical outcomes. These challenges are not limited to laparotomy. "With laparoscopy there are also difficulties with the surgery that we are all familiar with," Dr. Gallo said at the AAGL annual meeting.

Difficulty obtaining pneumoperitoneum secondary to preperitoneal fat, difficulty ventilating these women in steep Trendelenburg position, and difficulty gaining adequate exposure during surgery are among the challenges in this patient population, she added.

"In the gynecologic literature, few studies have addressed robotic surgery for the morbidly obese patient," Dr. Gallo said. So she and her colleagues retrospectively studied women who underwent robotic-assisted hysterectomy over a 4-year period in a single surgeon teaching practice. Dr. Masoud Azodi, the senior author and surgeon in this study, is director of the minimally invasive gynecologic surgery (MIGS) fellowship program at Yale University, New Haven.

A total of 58% of the 442 women were obese or morbidly obese, said Dr. Gallo, a gynecologist in private practice in Sebastian, Fla. She was a minimally invasive gynecologic surgery fellow at Bridgeport Hospital/Yale New Haven Health System in Connecticut at the time of the study.

"All BMI groups had similar outcomes," Dr. Gallo said. Median operative times, estimated blood loss, length of stay, and complication rates did not differ significantly among the nonobese women (BMI less than 30 kg/m², median 25 kg/m²); obese women (BMI of 30-39.9 kg/m², median 34 kg/m²); and morbidly obese women (BMI of 40 kg/m² or greater, median 44 kg/m²).

Median operative time for the entire cohort from skin incision to skin closure was 135 minutes. This included time for any concomitant procedures, such as lymphadenectomy or pelvic floor repair, she said. Median operative time by BMI group was similar: 141 minutes for the nonobese group, 135 minutes for the obese women, and 124 minutes for the morbidly obese.

Three patients, one in each BMI group, were converted to laparotomy, for an overall rate of 0.7%.

Median estimated blood loss overall and in each BMI group was 100 mL. Median length of hospital stay of 1 day, likewise, was the same overall and in each group.

The overall complication rate in the study was 12%. This figure includes a major complication rate of 4% (readmissions, reoperations) and a minor complication rate of 8%. "By BMI group, the complications – major, minor, or total – these did not differ," Dr. Gallo said.

Urinary complications affected 11 women (2.6%), including 1% who had bladder injuries recognized and repaired intraoperatively and 1.6% who had ureteral injuries. Two women with ureteral injuries were repaired with stenting, and four others required subsequent ureteral reimplantation, she said.

Bowel injuries occurred in six patients. Four cases were recognized and repaired intraoperatively, and two women required reoperation and bowel resection.

The remainder of the complications in the study occurred less than 1% of the time. One patient, in the nonobese BMI group, had a vaginal cuff dehiscence, for an overall rate of 0.2% in the study.

Patient demographics were similar between groups. For example, the median age was 51 years in the nonobese, 55 years in the obese, and 54 years in the morbidly obese groups. Women underwent hysterectomy for benign and malignant indications, including early endometrial cancer, early cervical cancer, and occult ovarian cancer.

The retrospective design of the study is a limitation, Dr. Gallo said, and no absolute conclusions can be drawn. "Also, our study was not adequately powered. We would have required more than 4,300 patients to detect a difference in operative time between BMI groups with a power of 80%."

She added, "Our study may not be generalizable to other surgeons or other institutions – this was a single surgeon with a high surgical volume and extensive experience in laparoscopic and robotic surgery.

"Despite these limitations, we believe our study offers clinically relevant information pertaining to the growing number of obese patients that will be faced by minimally invasive surgeons," she said.

Assessment of costs associated with robotic-assisted hysterectomy was outside the scope of this study.

Dr. Gallo said the minimally invasive gynecologic fellowship program at Yale has received an educational grant from Intuitive Surgical.

HOLLYWOOD, FLA. – Surgical outcomes of robotic-assisted hysterectomy did not differ significantly for women whether they were nonobese, obese, or morbidly obese, in a study of 442 women classified according to body mass index.

"Our findings reiterate the safety of robotic hysterectomy for the obese and morbidly obese patients," Dr. Taryn Gallo said. "As minimally invasive surgeons, we know every day we are facing bigger and bigger patients. You can’t underestimate the value of being able to offer these women a minimally invasive approach and sending them home the next day."

Approximately 34% of U.S. women are obese with a body mass index (BMI) of 30 kg/m2 or greater, according to the World Health Organization. Obesity and its comorbidities are well-known risk factors that affect surgical outcomes. These challenges are not limited to laparotomy. "With laparoscopy there are also difficulties with the surgery that we are all familiar with," Dr. Gallo said at the AAGL annual meeting.

Difficulty obtaining pneumoperitoneum secondary to preperitoneal fat, difficulty ventilating these women in steep Trendelenburg position, and difficulty gaining adequate exposure during surgery are among the challenges in this patient population, she added.

"In the gynecologic literature, few studies have addressed robotic surgery for the morbidly obese patient," Dr. Gallo said. So she and her colleagues retrospectively studied women who underwent robotic-assisted hysterectomy over a 4-year period in a single surgeon teaching practice. Dr. Masoud Azodi, the senior author and surgeon in this study, is director of the minimally invasive gynecologic surgery (MIGS) fellowship program at Yale University, New Haven.

A total of 58% of the 442 women were obese or morbidly obese, said Dr. Gallo, a gynecologist in private practice in Sebastian, Fla. She was a minimally invasive gynecologic surgery fellow at Bridgeport Hospital/Yale New Haven Health System in Connecticut at the time of the study.

"All BMI groups had similar outcomes," Dr. Gallo said. Median operative times, estimated blood loss, length of stay, and complication rates did not differ significantly among the nonobese women (BMI less than 30 kg/m², median 25 kg/m²); obese women (BMI of 30-39.9 kg/m², median 34 kg/m²); and morbidly obese women (BMI of 40 kg/m² or greater, median 44 kg/m²).

Median operative time for the entire cohort from skin incision to skin closure was 135 minutes. This included time for any concomitant procedures, such as lymphadenectomy or pelvic floor repair, she said. Median operative time by BMI group was similar: 141 minutes for the nonobese group, 135 minutes for the obese women, and 124 minutes for the morbidly obese.

Three patients, one in each BMI group, were converted to laparotomy, for an overall rate of 0.7%.

Median estimated blood loss overall and in each BMI group was 100 mL. Median length of hospital stay of 1 day, likewise, was the same overall and in each group.

The overall complication rate in the study was 12%. This figure includes a major complication rate of 4% (readmissions, reoperations) and a minor complication rate of 8%. "By BMI group, the complications – major, minor, or total – these did not differ," Dr. Gallo said.

Urinary complications affected 11 women (2.6%), including 1% who had bladder injuries recognized and repaired intraoperatively and 1.6% who had ureteral injuries. Two women with ureteral injuries were repaired with stenting, and four others required subsequent ureteral reimplantation, she said.

Bowel injuries occurred in six patients. Four cases were recognized and repaired intraoperatively, and two women required reoperation and bowel resection.

The remainder of the complications in the study occurred less than 1% of the time. One patient, in the nonobese BMI group, had a vaginal cuff dehiscence, for an overall rate of 0.2% in the study.

Patient demographics were similar between groups. For example, the median age was 51 years in the nonobese, 55 years in the obese, and 54 years in the morbidly obese groups. Women underwent hysterectomy for benign and malignant indications, including early endometrial cancer, early cervical cancer, and occult ovarian cancer.

The retrospective design of the study is a limitation, Dr. Gallo said, and no absolute conclusions can be drawn. "Also, our study was not adequately powered. We would have required more than 4,300 patients to detect a difference in operative time between BMI groups with a power of 80%."

She added, "Our study may not be generalizable to other surgeons or other institutions – this was a single surgeon with a high surgical volume and extensive experience in laparoscopic and robotic surgery.

"Despite these limitations, we believe our study offers clinically relevant information pertaining to the growing number of obese patients that will be faced by minimally invasive surgeons," she said.

Assessment of costs associated with robotic-assisted hysterectomy was outside the scope of this study.

Dr. Gallo said the minimally invasive gynecologic fellowship program at Yale has received an educational grant from Intuitive Surgical.

ORLANDO – A simple regimen change – giving half the dose of clomiphene over twice as many days – significantly improved ovulation and pregnancy rates in a study of women with polycystic ovary syndrome and clomiphene-resistant anovulation.

The study involved 220 women who failed to respond to an initial regimen of clomiphene citrate. Dr. Mervat Omran compared outcomes between 110 women randomized to 200 mg clomiphene (four 50-mg tablets daily) for 5 days and 100 women randomized to 100 mg/day (two tablets) for 10 days.

The extended duration protocol resulted in a significantly higher ovulation rate, a higher number of dominant follicles, better endometrium at ovulation, and a higher pregnancy rate than the 5-day protocol, despite an equal total dose of clomiphene per cycle, Dr. Omran said at the meeting.

About 20%-25% of polycystic ovary syndrome (PCOS) patients have clomiphene-resistant anovulation, defined as a lack of ovulatory response after the standard dose of 100 mg/day for 5 days, Dr. Omran said.

One solution is to try to increase the amplitude or duration of treatment, said Dr. Omran, an ob.gyn. at the University of Alexandria (Egypt).

Women in the 10-day group had a significantly higher ovulation rate, 37%, compared with 10% in the 5-day group. Also, “the endometrium at ovulation was significantly thicker … and the clinical pregnancy rate was significantly higher in the longer duration group,” she said.

These regimens represent an off-label use in the United States. The Food and Drug Administration–recommended dosage is an initial 50 mg clomiphene per day for 5 days to stimulate ovulation. Unresponsive patients can be given 100 mg daily for 5 days, but increasing the dosage or duration of therapy beyond this dosage is not recommended.

“We should start by dosing no more than 100 mg clomiphene per day for 5 days,” Dr. Omran said, “but if the patient [does] not respond, I think it's better to prolong the duration than to increase the dose.”

It may be that longer exposure to clomiphene might increase stimulation of follicles in these patients to a greater degree than simply higher doses, Dr. Omran said.

“That's why I think your approach is interesting,” said session comoderator Dr. James Segars Jr. “You're saying, basically, maybe it takes a little longer duration to get physiologic effect, and you clearly showed there is a big difference.”

“We typically give Clomid 50s for 5 days. Maybe the next logical step is to look at 50 mg for 10 days” and then try 100 mg for 10 days if response remains suboptimal, said Dr. Segars of the National Institute of Child Health and Human Development in Bethesda, Md.

Measurement of serum follicle stimulating hormone (FSH) and luteinizing hormone (LH) on day 6 and day 10 were strengths of the study, Dr. Omran said. Day 6 FSH levels did not differ significantly between 6.9 mIU/mL in the 5-day group and 6.2 mIU/mL in the 10-day group. Therefore, the higher dose clomiphene regimen did not significantly increase the amplitude of FSH at day 6, she added.

“However, day 10 FSH was significantly higher in the group that used the longer regimen [6.3 mIU/mL versus 3.8 mIU/mL], indicating that prolonging the duration of treatment might be better than increasing the dose of clomiphene,” Dr. Omran said.

ORLANDO – A simple regimen change – giving half the dose of clomiphene over twice as many days – significantly improved ovulation and pregnancy rates in a study of women with polycystic ovary syndrome and clomiphene-resistant anovulation.

The study involved 220 women who failed to respond to an initial regimen of clomiphene citrate. Dr. Mervat Omran compared outcomes between 110 women randomized to 200 mg clomiphene (four 50-mg tablets daily) for 5 days and 100 women randomized to 100 mg/day (two tablets) for 10 days.

The extended duration protocol resulted in a significantly higher ovulation rate, a higher number of dominant follicles, better endometrium at ovulation, and a higher pregnancy rate than the 5-day protocol, despite an equal total dose of clomiphene per cycle, Dr. Omran said at the meeting.

About 20%-25% of polycystic ovary syndrome (PCOS) patients have clomiphene-resistant anovulation, defined as a lack of ovulatory response after the standard dose of 100 mg/day for 5 days, Dr. Omran said.

One solution is to try to increase the amplitude or duration of treatment, said Dr. Omran, an ob.gyn. at the University of Alexandria (Egypt).

Women in the 10-day group had a significantly higher ovulation rate, 37%, compared with 10% in the 5-day group. Also, “the endometrium at ovulation was significantly thicker … and the clinical pregnancy rate was significantly higher in the longer duration group,” she said.

These regimens represent an off-label use in the United States. The Food and Drug Administration–recommended dosage is an initial 50 mg clomiphene per day for 5 days to stimulate ovulation. Unresponsive patients can be given 100 mg daily for 5 days, but increasing the dosage or duration of therapy beyond this dosage is not recommended.

“We should start by dosing no more than 100 mg clomiphene per day for 5 days,” Dr. Omran said, “but if the patient [does] not respond, I think it's better to prolong the duration than to increase the dose.”

It may be that longer exposure to clomiphene might increase stimulation of follicles in these patients to a greater degree than simply higher doses, Dr. Omran said.

“That's why I think your approach is interesting,” said session comoderator Dr. James Segars Jr. “You're saying, basically, maybe it takes a little longer duration to get physiologic effect, and you clearly showed there is a big difference.”

“We typically give Clomid 50s for 5 days. Maybe the next logical step is to look at 50 mg for 10 days” and then try 100 mg for 10 days if response remains suboptimal, said Dr. Segars of the National Institute of Child Health and Human Development in Bethesda, Md.

Measurement of serum follicle stimulating hormone (FSH) and luteinizing hormone (LH) on day 6 and day 10 were strengths of the study, Dr. Omran said. Day 6 FSH levels did not differ significantly between 6.9 mIU/mL in the 5-day group and 6.2 mIU/mL in the 10-day group. Therefore, the higher dose clomiphene regimen did not significantly increase the amplitude of FSH at day 6, she added.

“However, day 10 FSH was significantly higher in the group that used the longer regimen [6.3 mIU/mL versus 3.8 mIU/mL], indicating that prolonging the duration of treatment might be better than increasing the dose of clomiphene,” Dr. Omran said.

ORLANDO – A simple regimen change – giving half the dose of clomiphene over twice as many days – significantly improved ovulation and pregnancy rates in a study of women with polycystic ovary syndrome and clomiphene-resistant anovulation.

The study involved 220 women who failed to respond to an initial regimen of clomiphene citrate. Dr. Mervat Omran compared outcomes between 110 women randomized to 200 mg clomiphene (four 50-mg tablets daily) for 5 days and 100 women randomized to 100 mg/day (two tablets) for 10 days.

The extended duration protocol resulted in a significantly higher ovulation rate, a higher number of dominant follicles, better endometrium at ovulation, and a higher pregnancy rate than the 5-day protocol, despite an equal total dose of clomiphene per cycle, Dr. Omran said at the meeting.

About 20%-25% of polycystic ovary syndrome (PCOS) patients have clomiphene-resistant anovulation, defined as a lack of ovulatory response after the standard dose of 100 mg/day for 5 days, Dr. Omran said.

One solution is to try to increase the amplitude or duration of treatment, said Dr. Omran, an ob.gyn. at the University of Alexandria (Egypt).

Women in the 10-day group had a significantly higher ovulation rate, 37%, compared with 10% in the 5-day group. Also, “the endometrium at ovulation was significantly thicker … and the clinical pregnancy rate was significantly higher in the longer duration group,” she said.

These regimens represent an off-label use in the United States. The Food and Drug Administration–recommended dosage is an initial 50 mg clomiphene per day for 5 days to stimulate ovulation. Unresponsive patients can be given 100 mg daily for 5 days, but increasing the dosage or duration of therapy beyond this dosage is not recommended.

“We should start by dosing no more than 100 mg clomiphene per day for 5 days,” Dr. Omran said, “but if the patient [does] not respond, I think it's better to prolong the duration than to increase the dose.”

It may be that longer exposure to clomiphene might increase stimulation of follicles in these patients to a greater degree than simply higher doses, Dr. Omran said.

“That's why I think your approach is interesting,” said session comoderator Dr. James Segars Jr. “You're saying, basically, maybe it takes a little longer duration to get physiologic effect, and you clearly showed there is a big difference.”

“We typically give Clomid 50s for 5 days. Maybe the next logical step is to look at 50 mg for 10 days” and then try 100 mg for 10 days if response remains suboptimal, said Dr. Segars of the National Institute of Child Health and Human Development in Bethesda, Md.

Measurement of serum follicle stimulating hormone (FSH) and luteinizing hormone (LH) on day 6 and day 10 were strengths of the study, Dr. Omran said. Day 6 FSH levels did not differ significantly between 6.9 mIU/mL in the 5-day group and 6.2 mIU/mL in the 10-day group. Therefore, the higher dose clomiphene regimen did not significantly increase the amplitude of FSH at day 6, she added.

“However, day 10 FSH was significantly higher in the group that used the longer regimen [6.3 mIU/mL versus 3.8 mIU/mL], indicating that prolonging the duration of treatment might be better than increasing the dose of clomiphene,” Dr. Omran said.

ORLANDO – Although many physicians first recommend superovulation treatment in a stepwise approach to infertility, a study has shown that immediate in vitro fertilization yields significantly higher pregnancy and live birth rates for couples trying to conceive when the woman is aged 38-43 years.

“Older women have special considerations, including a limited window of opportunity for becoming pregnant,” Dr. Richard H. Reindollar said at the meeting.”

“My recommendation would be when couples come in after 6 months of trying to conceive that they be shown this as an option. If money is not a factor, IVF is the most effective strategy,” said Dr. Reindollar, chair of the department of obstetrics and gynecology, Dartmouth-Hitchcock Medical Center, Lebanon, N.H.

To determine the optimal strategy, researchers randomized 154 older women with unexplained infertility to clomiphene, follicle-stimulating hormone (FSH), or immediate in vitro fertilization (IVF). Participants assigned to clomiphene received 100 mg for 5 days and one intrauterine insemination (IUI) for two cycles. Those in the FSH group received 225 IU for 5 days plus one IUI for two cycles. The rest underwent immediate IVF.

All women were part of couples who had tried to conceive unsuccessfully for at least 6 months.

The primary aim was to compare the effectiveness of these strategies after two treatment cycles. After two cycles, 51 couples underwent a total of 87 clomiphene/IUI cycles; 52 couples underwent 91 FSH/IUI cycles; and 51 couples had 85 immediate IVF cycles.

Immediate IVF is the most effective treatment for couples when the female partner is at the end of her reproductive years, Dr. Reindollar said when presenting these preliminary results of the Forty and Over Infertility Treatment Trial (FORT-T). Cost analysis of the data is planned for the future.

Per cycle, 7% of the women in the clomiphene/IUI group had a clinically recognized pregnancy, compared with 8% in the FSH/IUI arm and 25% in the IVF group.

When the two fertility treatment groups were combined, the live birth rate was 5% (9 of 178 treatment cycles), compared with 15% for women in the IVF group (13 of the 85 treatment cycles).

“The use of FSH/IUI has come under scrutiny in the past few years,” Dr. Reindollar said. Pregnancy rates below 10% and a high rate of multiple births, including triplets and quadruplets, are among the criticisms.

He conducted a previous randomized trial of women younger than 40 years with unexplained infertility (Fertil. Steril. 2010;94:888-99). Dr. Reindollar and his colleagues determined that FSH/IUI provides no added value to a regimen of three cycles of clomiphene and up to six cycles of IVF in terms of cost-effectiveness and time for a pregnancy to lead to a live birth.

For the current study, determination of the overall effectiveness of the three treatment strategies, even beyond the first two cycles, was a secondary aim. After the first two cycles, all couples underwent four cycles of IVF. Follow-up of these couples ended Sept. 15, 2011. Overall, by study end, 46% of the women had achieved pregnancy (71 of the 154 participants).

“There was some catch-up in the clomiphene and FSH arms by the end of the trial,” Dr. Reindollar said. However, despite this catch-up in pregnancy rates, 70% of live births were achieved through IVF. “Beginning treatment with immediate IVF, compared with initial treatments of superovulation and IUI, results in [a] significantly higher number of live-born infants.”

Dr. Reindollar said he plans a future cost analysis of the data and will look at whether any significant differences emerge when patients are stratified by age (38-41 years vs. 42-43 years).

All the women in the study were fertility-treatment naive and had a normal clomiphene challenge test. In addition, participants had no pelvic pathology, had an acceptable ovarian reserve, and reported regular menstrual cycles. The male partners had normal semen analysis findings.

The groups did not differ significantly by demographics. The mean age of women was 40 years in the clomiphene and IVF groups and 41 in the FSH group. Approximately one in five in each group was older than 41 years. The majority of each group reported no prior deliveries: 67% of the clomiphene patients, 79% of the FSH patients, and 69% of IVF patients. In addition, more than 75% of participants were white and more than 80% had a history of oral contraceptive use.

ORLANDO – Although many physicians first recommend superovulation treatment in a stepwise approach to infertility, a study has shown that immediate in vitro fertilization yields significantly higher pregnancy and live birth rates for couples trying to conceive when the woman is aged 38-43 years.

“Older women have special considerations, including a limited window of opportunity for becoming pregnant,” Dr. Richard H. Reindollar said at the meeting.”

“My recommendation would be when couples come in after 6 months of trying to conceive that they be shown this as an option. If money is not a factor, IVF is the most effective strategy,” said Dr. Reindollar, chair of the department of obstetrics and gynecology, Dartmouth-Hitchcock Medical Center, Lebanon, N.H.

To determine the optimal strategy, researchers randomized 154 older women with unexplained infertility to clomiphene, follicle-stimulating hormone (FSH), or immediate in vitro fertilization (IVF). Participants assigned to clomiphene received 100 mg for 5 days and one intrauterine insemination (IUI) for two cycles. Those in the FSH group received 225 IU for 5 days plus one IUI for two cycles. The rest underwent immediate IVF.

All women were part of couples who had tried to conceive unsuccessfully for at least 6 months.

The primary aim was to compare the effectiveness of these strategies after two treatment cycles. After two cycles, 51 couples underwent a total of 87 clomiphene/IUI cycles; 52 couples underwent 91 FSH/IUI cycles; and 51 couples had 85 immediate IVF cycles.

Immediate IVF is the most effective treatment for couples when the female partner is at the end of her reproductive years, Dr. Reindollar said when presenting these preliminary results of the Forty and Over Infertility Treatment Trial (FORT-T). Cost analysis of the data is planned for the future.

Per cycle, 7% of the women in the clomiphene/IUI group had a clinically recognized pregnancy, compared with 8% in the FSH/IUI arm and 25% in the IVF group.

When the two fertility treatment groups were combined, the live birth rate was 5% (9 of 178 treatment cycles), compared with 15% for women in the IVF group (13 of the 85 treatment cycles).

“The use of FSH/IUI has come under scrutiny in the past few years,” Dr. Reindollar said. Pregnancy rates below 10% and a high rate of multiple births, including triplets and quadruplets, are among the criticisms.

He conducted a previous randomized trial of women younger than 40 years with unexplained infertility (Fertil. Steril. 2010;94:888-99). Dr. Reindollar and his colleagues determined that FSH/IUI provides no added value to a regimen of three cycles of clomiphene and up to six cycles of IVF in terms of cost-effectiveness and time for a pregnancy to lead to a live birth.

For the current study, determination of the overall effectiveness of the three treatment strategies, even beyond the first two cycles, was a secondary aim. After the first two cycles, all couples underwent four cycles of IVF. Follow-up of these couples ended Sept. 15, 2011. Overall, by study end, 46% of the women had achieved pregnancy (71 of the 154 participants).

“There was some catch-up in the clomiphene and FSH arms by the end of the trial,” Dr. Reindollar said. However, despite this catch-up in pregnancy rates, 70% of live births were achieved through IVF. “Beginning treatment with immediate IVF, compared with initial treatments of superovulation and IUI, results in [a] significantly higher number of live-born infants.”

Dr. Reindollar said he plans a future cost analysis of the data and will look at whether any significant differences emerge when patients are stratified by age (38-41 years vs. 42-43 years).

All the women in the study were fertility-treatment naive and had a normal clomiphene challenge test. In addition, participants had no pelvic pathology, had an acceptable ovarian reserve, and reported regular menstrual cycles. The male partners had normal semen analysis findings.

The groups did not differ significantly by demographics. The mean age of women was 40 years in the clomiphene and IVF groups and 41 in the FSH group. Approximately one in five in each group was older than 41 years. The majority of each group reported no prior deliveries: 67% of the clomiphene patients, 79% of the FSH patients, and 69% of IVF patients. In addition, more than 75% of participants were white and more than 80% had a history of oral contraceptive use.

ORLANDO – Although many physicians first recommend superovulation treatment in a stepwise approach to infertility, a study has shown that immediate in vitro fertilization yields significantly higher pregnancy and live birth rates for couples trying to conceive when the woman is aged 38-43 years.

“Older women have special considerations, including a limited window of opportunity for becoming pregnant,” Dr. Richard H. Reindollar said at the meeting.”

“My recommendation would be when couples come in after 6 months of trying to conceive that they be shown this as an option. If money is not a factor, IVF is the most effective strategy,” said Dr. Reindollar, chair of the department of obstetrics and gynecology, Dartmouth-Hitchcock Medical Center, Lebanon, N.H.

To determine the optimal strategy, researchers randomized 154 older women with unexplained infertility to clomiphene, follicle-stimulating hormone (FSH), or immediate in vitro fertilization (IVF). Participants assigned to clomiphene received 100 mg for 5 days and one intrauterine insemination (IUI) for two cycles. Those in the FSH group received 225 IU for 5 days plus one IUI for two cycles. The rest underwent immediate IVF.

All women were part of couples who had tried to conceive unsuccessfully for at least 6 months.

The primary aim was to compare the effectiveness of these strategies after two treatment cycles. After two cycles, 51 couples underwent a total of 87 clomiphene/IUI cycles; 52 couples underwent 91 FSH/IUI cycles; and 51 couples had 85 immediate IVF cycles.

Immediate IVF is the most effective treatment for couples when the female partner is at the end of her reproductive years, Dr. Reindollar said when presenting these preliminary results of the Forty and Over Infertility Treatment Trial (FORT-T). Cost analysis of the data is planned for the future.

Per cycle, 7% of the women in the clomiphene/IUI group had a clinically recognized pregnancy, compared with 8% in the FSH/IUI arm and 25% in the IVF group.

When the two fertility treatment groups were combined, the live birth rate was 5% (9 of 178 treatment cycles), compared with 15% for women in the IVF group (13 of the 85 treatment cycles).

“The use of FSH/IUI has come under scrutiny in the past few years,” Dr. Reindollar said. Pregnancy rates below 10% and a high rate of multiple births, including triplets and quadruplets, are among the criticisms.

He conducted a previous randomized trial of women younger than 40 years with unexplained infertility (Fertil. Steril. 2010;94:888-99). Dr. Reindollar and his colleagues determined that FSH/IUI provides no added value to a regimen of three cycles of clomiphene and up to six cycles of IVF in terms of cost-effectiveness and time for a pregnancy to lead to a live birth.

For the current study, determination of the overall effectiveness of the three treatment strategies, even beyond the first two cycles, was a secondary aim. After the first two cycles, all couples underwent four cycles of IVF. Follow-up of these couples ended Sept. 15, 2011. Overall, by study end, 46% of the women had achieved pregnancy (71 of the 154 participants).

“There was some catch-up in the clomiphene and FSH arms by the end of the trial,” Dr. Reindollar said. However, despite this catch-up in pregnancy rates, 70% of live births were achieved through IVF. “Beginning treatment with immediate IVF, compared with initial treatments of superovulation and IUI, results in [a] significantly higher number of live-born infants.”

Dr. Reindollar said he plans a future cost analysis of the data and will look at whether any significant differences emerge when patients are stratified by age (38-41 years vs. 42-43 years).

All the women in the study were fertility-treatment naive and had a normal clomiphene challenge test. In addition, participants had no pelvic pathology, had an acceptable ovarian reserve, and reported regular menstrual cycles. The male partners had normal semen analysis findings.

The groups did not differ significantly by demographics. The mean age of women was 40 years in the clomiphene and IVF groups and 41 in the FSH group. Approximately one in five in each group was older than 41 years. The majority of each group reported no prior deliveries: 67% of the clomiphene patients, 79% of the FSH patients, and 69% of IVF patients. In addition, more than 75% of participants were white and more than 80% had a history of oral contraceptive use.

ORLANDO – Uterine fibroids are bad for pregnancy and neonatal outcomes, and a new study shows just how bad.

Women diagnosed with fibroids on their first obstetric ultrasound examination, for example, were significantly more likely to experience preterm labor or preterm premature rupture of the membranes (pPROM). Also, significantly more deliver before 37 weeks' gestation or via cesarean section, compared with a group of women without these noncancerous growths of the uterus.

Dr. Radwan Asaad and his colleagues compared 152 women with fibroids to another 165 matched controls in a retrospective cohort analysis conducted at Wayne State University, Detroit. They also found fibroids weren't good news for the baby either.

“Uterine fibroids complicate the pregnancy course as evidenced by a considerable impact on the obstetrical and neonatal outcomes,” Dr. Asaad said at the meeting.

In terms of the significantly different maternal numbers, women with fibroids were more likely to experience preterm labor (16.4% vs. 2.4% of controls), and pPROM (15.8% vs. 3.6%), and to deliver preterm (33.3% vs. 10.1%).

Fetal malpresentation also was significantly more likely in the fibroid group (22% vs. 6% in controls). Cesarean delivery occurred in 54.3% of the fibroid group vs. 28.0% of the control group, another significant difference.

Gestational age at delivery was significantly less when the mother had fibroids (mean 35.3 weeks) vs. without (38.6 weeks).

Children born to women in the fibroid group had a mean birth weight of 2,634 g, compared with 3,181 g for those born to control group women. Apgar scores at 1 minute were a mean 6.7 vs. 7.8 in the control group and at 5 minutes were a mean 7.9 vs. 8.8.

Pregnancy loss was higher in the fibroid group during the first trimester (7.9% vs. 3.6% in controls) and during the second trimester (5.9% vs. 1.2%), but these differences were not statistically significant to the P less than .001 level. A trend toward more arrested dilation in the fibroid group likewise did not reach significance.

“Uterine myomas are the most common pelvic tumor in reproductive-age women,” said Dr. Asaad, a laparoscopic and minimally invasive surgeon in the department of obstetrics and gynecology at Hutzel Women's Hospital and Wayne State University/Detroit Medical Center. Prevalence in published studies varies from 2% to 11%, depending on the trimester in which they are measured and the size threshold chosen by researchers.

A meeting attendee asked for information on the size and anatomic location of the fibroids. Dr. Asaad replied that he was only able to categorize women dichotomously as yes/no for presence of fibroids in this retrospective study.

Dr. Asaad and his associates reviewed all department ultrasounds from 1998 to 2006 at their tertiary care center. Women with complete records in the fibroid group were matched to controls for age, gravidity, parity, and year of delivery.

He said he had no relevant financial disclosures.

ORLANDO – Uterine fibroids are bad for pregnancy and neonatal outcomes, and a new study shows just how bad.

Women diagnosed with fibroids on their first obstetric ultrasound examination, for example, were significantly more likely to experience preterm labor or preterm premature rupture of the membranes (pPROM). Also, significantly more deliver before 37 weeks' gestation or via cesarean section, compared with a group of women without these noncancerous growths of the uterus.

Dr. Radwan Asaad and his colleagues compared 152 women with fibroids to another 165 matched controls in a retrospective cohort analysis conducted at Wayne State University, Detroit. They also found fibroids weren't good news for the baby either.

“Uterine fibroids complicate the pregnancy course as evidenced by a considerable impact on the obstetrical and neonatal outcomes,” Dr. Asaad said at the meeting.

In terms of the significantly different maternal numbers, women with fibroids were more likely to experience preterm labor (16.4% vs. 2.4% of controls), and pPROM (15.8% vs. 3.6%), and to deliver preterm (33.3% vs. 10.1%).

Fetal malpresentation also was significantly more likely in the fibroid group (22% vs. 6% in controls). Cesarean delivery occurred in 54.3% of the fibroid group vs. 28.0% of the control group, another significant difference.

Gestational age at delivery was significantly less when the mother had fibroids (mean 35.3 weeks) vs. without (38.6 weeks).

Children born to women in the fibroid group had a mean birth weight of 2,634 g, compared with 3,181 g for those born to control group women. Apgar scores at 1 minute were a mean 6.7 vs. 7.8 in the control group and at 5 minutes were a mean 7.9 vs. 8.8.

Pregnancy loss was higher in the fibroid group during the first trimester (7.9% vs. 3.6% in controls) and during the second trimester (5.9% vs. 1.2%), but these differences were not statistically significant to the P less than .001 level. A trend toward more arrested dilation in the fibroid group likewise did not reach significance.

“Uterine myomas are the most common pelvic tumor in reproductive-age women,” said Dr. Asaad, a laparoscopic and minimally invasive surgeon in the department of obstetrics and gynecology at Hutzel Women's Hospital and Wayne State University/Detroit Medical Center. Prevalence in published studies varies from 2% to 11%, depending on the trimester in which they are measured and the size threshold chosen by researchers.

A meeting attendee asked for information on the size and anatomic location of the fibroids. Dr. Asaad replied that he was only able to categorize women dichotomously as yes/no for presence of fibroids in this retrospective study.

Dr. Asaad and his associates reviewed all department ultrasounds from 1998 to 2006 at their tertiary care center. Women with complete records in the fibroid group were matched to controls for age, gravidity, parity, and year of delivery.

He said he had no relevant financial disclosures.

ORLANDO – Uterine fibroids are bad for pregnancy and neonatal outcomes, and a new study shows just how bad.

Women diagnosed with fibroids on their first obstetric ultrasound examination, for example, were significantly more likely to experience preterm labor or preterm premature rupture of the membranes (pPROM). Also, significantly more deliver before 37 weeks' gestation or via cesarean section, compared with a group of women without these noncancerous growths of the uterus.

Dr. Radwan Asaad and his colleagues compared 152 women with fibroids to another 165 matched controls in a retrospective cohort analysis conducted at Wayne State University, Detroit. They also found fibroids weren't good news for the baby either.

“Uterine fibroids complicate the pregnancy course as evidenced by a considerable impact on the obstetrical and neonatal outcomes,” Dr. Asaad said at the meeting.

In terms of the significantly different maternal numbers, women with fibroids were more likely to experience preterm labor (16.4% vs. 2.4% of controls), and pPROM (15.8% vs. 3.6%), and to deliver preterm (33.3% vs. 10.1%).

Fetal malpresentation also was significantly more likely in the fibroid group (22% vs. 6% in controls). Cesarean delivery occurred in 54.3% of the fibroid group vs. 28.0% of the control group, another significant difference.

Gestational age at delivery was significantly less when the mother had fibroids (mean 35.3 weeks) vs. without (38.6 weeks).

Children born to women in the fibroid group had a mean birth weight of 2,634 g, compared with 3,181 g for those born to control group women. Apgar scores at 1 minute were a mean 6.7 vs. 7.8 in the control group and at 5 minutes were a mean 7.9 vs. 8.8.

Pregnancy loss was higher in the fibroid group during the first trimester (7.9% vs. 3.6% in controls) and during the second trimester (5.9% vs. 1.2%), but these differences were not statistically significant to the P less than .001 level. A trend toward more arrested dilation in the fibroid group likewise did not reach significance.

“Uterine myomas are the most common pelvic tumor in reproductive-age women,” said Dr. Asaad, a laparoscopic and minimally invasive surgeon in the department of obstetrics and gynecology at Hutzel Women's Hospital and Wayne State University/Detroit Medical Center. Prevalence in published studies varies from 2% to 11%, depending on the trimester in which they are measured and the size threshold chosen by researchers.

A meeting attendee asked for information on the size and anatomic location of the fibroids. Dr. Asaad replied that he was only able to categorize women dichotomously as yes/no for presence of fibroids in this retrospective study.

Dr. Asaad and his associates reviewed all department ultrasounds from 1998 to 2006 at their tertiary care center. Women with complete records in the fibroid group were matched to controls for age, gravidity, parity, and year of delivery.

He said he had no relevant financial disclosures.

BOCA RATON, FLA. – Ovarian suppression to treat endometriosis might cause a woman to experience significantly more migraines, and more sleep disturbances, numbness, joint pain, hot flashes, and heart palpitations, a study showed. Some women also experience more depression.

Migraines affect more than three times as many women as men in the United States. Decreases in hormone levels and sex steroids in the late luteal phase of the menstrual period, during the postpartum period, and during perimenopause, for example, can increase a woman's susceptibility to migraines. Researchers noted that treatments that lower a woman's estrogen levels to tackle endometriosis might, at the same time, increase her risk for more severe and more frequent migraines and depressive symptoms.

Dr. Julia K. Warnock said that gonadotropin-releasing hormone (GnRH) agonists will decrease estrogen and increase the risk of headaches, including migraines, and increase the risk for depressive symptoms. Some women are more sensitive to mood-related hormonal changes, said Dr. Warnock, professor of psychiatry and director of clinical research at the University of Oklahoma Health Science Center in Tulsa.

“As the patient transitions through the reproductive cycle, a number of [her] associated mood symptoms … are influenced by fluctuations in estrogen,” said study coauthor Dr. J. Clark Bundren, an ob.gyn. in private practice in Tulsa. “Proper supplementation of low-dose estradiol in this population can improve migraine headache, anxiety, and depression,” Dr. Bundren said.

Dr. Warnock and colleagues evaluated baseline hormone levels, depression, and physical symptoms for 56 women with endometriosis. They completed the MENSI (Menopause Symptom Index) and the HAM-D (Hamilton Rating Scale for Depression). They were then treated with 3.75 mg GnRH agonist via intramuscular injection daily for 28 days, and reevaluated at 1 month, 2 months, and 5 months.

A significant increase in the frequency of headaches was observed at each follow-up, according to an item level chi square analysis of MENSI scores, compared with baseline. Total MENSI scores likewise significantly increased at 1, 3, and 5 months, according to a t-test of dependent samples. Similarly, depressive symptoms significantly increased, compared with baseline, at months 1, 3, and 5, as reflected by the percentages of women who scored greater than 10 on the HAM-D.

“Psychiatrists should consider hormonal fluctuations in the treatment of women [with depression],” Dr. Warnock said, because decreases in estrogen levels can predispose some to worsening depression. Combination hormone and antidepressant treatment can have synergistic benefits. “Together is better.” This dual approach also can mean lower doses of antidepressants and therefore, lower risk of associated adverse events.

As for the risks associated with hormone therapy, Dr. Bundren said, “Women on estrogen alone have a decreased risk of breast cancer, but it's not a simple message.”

“It matters which estrogen, which patient, and how it's delivered,” Dr. Warnock said. “In general, transdermal is better than oral. For women who are suffering, it's about their quality of life.”

The study was limited by patient self-report of headache frequency on the MENSI, and a lack of assessment of progesterone or its metabolites.

The study was unfunded. Dr. Warnock and Dr. Bundren said they had no relevant disclosures.

BOCA RATON, FLA. – Ovarian suppression to treat endometriosis might cause a woman to experience significantly more migraines, and more sleep disturbances, numbness, joint pain, hot flashes, and heart palpitations, a study showed. Some women also experience more depression.

Migraines affect more than three times as many women as men in the United States. Decreases in hormone levels and sex steroids in the late luteal phase of the menstrual period, during the postpartum period, and during perimenopause, for example, can increase a woman's susceptibility to migraines. Researchers noted that treatments that lower a woman's estrogen levels to tackle endometriosis might, at the same time, increase her risk for more severe and more frequent migraines and depressive symptoms.

Dr. Julia K. Warnock said that gonadotropin-releasing hormone (GnRH) agonists will decrease estrogen and increase the risk of headaches, including migraines, and increase the risk for depressive symptoms. Some women are more sensitive to mood-related hormonal changes, said Dr. Warnock, professor of psychiatry and director of clinical research at the University of Oklahoma Health Science Center in Tulsa.

“As the patient transitions through the reproductive cycle, a number of [her] associated mood symptoms … are influenced by fluctuations in estrogen,” said study coauthor Dr. J. Clark Bundren, an ob.gyn. in private practice in Tulsa. “Proper supplementation of low-dose estradiol in this population can improve migraine headache, anxiety, and depression,” Dr. Bundren said.

Dr. Warnock and colleagues evaluated baseline hormone levels, depression, and physical symptoms for 56 women with endometriosis. They completed the MENSI (Menopause Symptom Index) and the HAM-D (Hamilton Rating Scale for Depression). They were then treated with 3.75 mg GnRH agonist via intramuscular injection daily for 28 days, and reevaluated at 1 month, 2 months, and 5 months.

A significant increase in the frequency of headaches was observed at each follow-up, according to an item level chi square analysis of MENSI scores, compared with baseline. Total MENSI scores likewise significantly increased at 1, 3, and 5 months, according to a t-test of dependent samples. Similarly, depressive symptoms significantly increased, compared with baseline, at months 1, 3, and 5, as reflected by the percentages of women who scored greater than 10 on the HAM-D.

“Psychiatrists should consider hormonal fluctuations in the treatment of women [with depression],” Dr. Warnock said, because decreases in estrogen levels can predispose some to worsening depression. Combination hormone and antidepressant treatment can have synergistic benefits. “Together is better.” This dual approach also can mean lower doses of antidepressants and therefore, lower risk of associated adverse events.

As for the risks associated with hormone therapy, Dr. Bundren said, “Women on estrogen alone have a decreased risk of breast cancer, but it's not a simple message.”

“It matters which estrogen, which patient, and how it's delivered,” Dr. Warnock said. “In general, transdermal is better than oral. For women who are suffering, it's about their quality of life.”

The study was limited by patient self-report of headache frequency on the MENSI, and a lack of assessment of progesterone or its metabolites.

The study was unfunded. Dr. Warnock and Dr. Bundren said they had no relevant disclosures.

BOCA RATON, FLA. – Ovarian suppression to treat endometriosis might cause a woman to experience significantly more migraines, and more sleep disturbances, numbness, joint pain, hot flashes, and heart palpitations, a study showed. Some women also experience more depression.

Migraines affect more than three times as many women as men in the United States. Decreases in hormone levels and sex steroids in the late luteal phase of the menstrual period, during the postpartum period, and during perimenopause, for example, can increase a woman's susceptibility to migraines. Researchers noted that treatments that lower a woman's estrogen levels to tackle endometriosis might, at the same time, increase her risk for more severe and more frequent migraines and depressive symptoms.

Dr. Julia K. Warnock said that gonadotropin-releasing hormone (GnRH) agonists will decrease estrogen and increase the risk of headaches, including migraines, and increase the risk for depressive symptoms. Some women are more sensitive to mood-related hormonal changes, said Dr. Warnock, professor of psychiatry and director of clinical research at the University of Oklahoma Health Science Center in Tulsa.

“As the patient transitions through the reproductive cycle, a number of [her] associated mood symptoms … are influenced by fluctuations in estrogen,” said study coauthor Dr. J. Clark Bundren, an ob.gyn. in private practice in Tulsa. “Proper supplementation of low-dose estradiol in this population can improve migraine headache, anxiety, and depression,” Dr. Bundren said.

Dr. Warnock and colleagues evaluated baseline hormone levels, depression, and physical symptoms for 56 women with endometriosis. They completed the MENSI (Menopause Symptom Index) and the HAM-D (Hamilton Rating Scale for Depression). They were then treated with 3.75 mg GnRH agonist via intramuscular injection daily for 28 days, and reevaluated at 1 month, 2 months, and 5 months.

A significant increase in the frequency of headaches was observed at each follow-up, according to an item level chi square analysis of MENSI scores, compared with baseline. Total MENSI scores likewise significantly increased at 1, 3, and 5 months, according to a t-test of dependent samples. Similarly, depressive symptoms significantly increased, compared with baseline, at months 1, 3, and 5, as reflected by the percentages of women who scored greater than 10 on the HAM-D.

“Psychiatrists should consider hormonal fluctuations in the treatment of women [with depression],” Dr. Warnock said, because decreases in estrogen levels can predispose some to worsening depression. Combination hormone and antidepressant treatment can have synergistic benefits. “Together is better.” This dual approach also can mean lower doses of antidepressants and therefore, lower risk of associated adverse events.

As for the risks associated with hormone therapy, Dr. Bundren said, “Women on estrogen alone have a decreased risk of breast cancer, but it's not a simple message.”

“It matters which estrogen, which patient, and how it's delivered,” Dr. Warnock said. “In general, transdermal is better than oral. For women who are suffering, it's about their quality of life.”

The study was limited by patient self-report of headache frequency on the MENSI, and a lack of assessment of progesterone or its metabolites.

The study was unfunded. Dr. Warnock and Dr. Bundren said they had no relevant disclosures.

ORLANDO – A first of its kind study shows maternal weight does not play a role in pregnancy success via intrauterine insemination, in stark contrast to multiple trials that indicate as obesity increases, the chances for a woman to conceive via in vitro fertilization drop.

“We found no association between BMI [body mass index] and fecundability in women undergoing insemination,” Dr. LaTasha B. Craig said.

She and her associates reviewed 1,120 cycles of intrauterine insemination (IUI), including donor inseminations, performed July 2007 to June 2010 at a University of Oklahoma, Oklahoma City, infertility clinic. They noted the maternal body mass index within 6 months of initiation of IUI and classified 403 women according to National Institutes of Health BMI categories.

There were 152 pregnancies. The pregnancy rate was 7% in the underweight group; 12% in the normal weight group; 15% among overweight women; 11% in the obesity class I group; 12% in the class II group; and 20% in the class III obese women. None of these differences were statistically significant.

“Obesity is increasing and, I dare say, it's pandemic now. There is probably no better place to see it in the United States now than Oklahoma,” Dr. Craig said. According to 2010 data, one-third of the state population was obese with a BMI greater than 30 kg/m

“We need information to counsel [patients] on what the realistic expectations are with obesity,” Dr. Craig said at the meeting. “It turns out there is not much information about obesity and insemination outside the PCOS [polycystic ovarian syndrome] population.”

The effect of obesity in the study remained nonsignificant after researchers adjusted for patient age, total motile sperm count, duration of infertility, diagnosis, source of sperm, and use of fertility medication. In addition, increased BMI had no significant impact when comparing subpopulations with and without ovulatory dysfunction.

“This is the first study evaluating effects of BMI on all women undergoing insemination in a real world scenario, regardless of diagnosis or medication used,” said Dr. Craig, an ob.gyn. specializing in reproductive endocrinology and fertility at the University of Oklahoma.

The current findings add to the limited and conflicting literature. One study, for example, found a negative effect with increasing body weight. Researchers assessed 1,144 ovulatory, married women undergoing superovulation treatment and donor insemination (Arch. Androl. 2002;48:323-7). Pregnancy rates were significantly lower as BMI increased. For example, 42% of women with a BMI of 20-24 kg/m

Another study looked at insemination of 333 ovulatory women and, similar to the current study, found no association between BMI and fecundity (Fert. Steril. 2006;86:642-6).

“To make things more confusing, Wang et al. from Australia found a positive effect of being overweight or obese in a study of 2,040 women undergoing controlled ovarian hyperstimulation and IUI,” Dr. Craig said (Fert. Ster. 2004;81:1710-2).

In contrast, there is more of a consensus among recent trials that increased BMI is associated with decreased pregnancy rates through in vitro fertilization. For example, in a study of 45,163 assisted reproduction embryo transfers in 2007, increases in obesity were associated with lower clinical pregnancy and live birth weights (Human Reprod. 2011:26:245-52). In another example, for each increase in BMI point over 29 kg/m

“My personal belief on our differences, compared [with] the ART data, is ART is not physiologically normal. Superphysiologic estradiol levels and what we do with ovarian stimulation may exacerbate the metabolic abnormalities that come out with obesity,” Dr. Craig said, “and/or we are getting these patients pregnant with less-aggressive treatment.”

Participants in the current study underwent a mean of 2.6 IUI cycles and their mean age was 33 years. There were multiple reasons for insemination, but male factor infertility was the leading indication.

During the Q & A session, the moderator asked why the lower pregnancy rate in the underweight BMI group and nearly double rate in the highest weight category were not statistically significant. Dr. Craig explained that these two categories had relatively fewer cycles (29 and 46, respectively), compared with the other groups.

A large cohort, adjustment for multiple confounders, and inclusion of almost all insemination cycles over 3 years were strengths of the study, Dr. Craig said. Only 49 cycles were excluded because the charts lacked BMI data. The retrospective design and an end point of fecundability rather than fecundity were limitations.

Fecundability is the ability or chance to conceive within a given cycle. Fecundity is chance of getting pregnant and delivering a child per cycle. So fecundity is a bit lower than fecundability because some patients will miscarry, rather than deliver, Dr. Craig said in a later interview. In the future, she would like to assess fecundity and the pregnancy rate per woman.

Dr. Craig said that she had no relevant financial disclosures.

To view a video of Dr. Craig, use the QR code or go to www.obgynnews.com

'We found no association between BMI and fecundability in women undergoing insemination.'

Source DR. CRAIG

ORLANDO – A first of its kind study shows maternal weight does not play a role in pregnancy success via intrauterine insemination, in stark contrast to multiple trials that indicate as obesity increases, the chances for a woman to conceive via in vitro fertilization drop.

“We found no association between BMI [body mass index] and fecundability in women undergoing insemination,” Dr. LaTasha B. Craig said.

She and her associates reviewed 1,120 cycles of intrauterine insemination (IUI), including donor inseminations, performed July 2007 to June 2010 at a University of Oklahoma, Oklahoma City, infertility clinic. They noted the maternal body mass index within 6 months of initiation of IUI and classified 403 women according to National Institutes of Health BMI categories.

There were 152 pregnancies. The pregnancy rate was 7% in the underweight group; 12% in the normal weight group; 15% among overweight women; 11% in the obesity class I group; 12% in the class II group; and 20% in the class III obese women. None of these differences were statistically significant.

“Obesity is increasing and, I dare say, it's pandemic now. There is probably no better place to see it in the United States now than Oklahoma,” Dr. Craig said. According to 2010 data, one-third of the state population was obese with a BMI greater than 30 kg/m

“We need information to counsel [patients] on what the realistic expectations are with obesity,” Dr. Craig said at the meeting. “It turns out there is not much information about obesity and insemination outside the PCOS [polycystic ovarian syndrome] population.”

The effect of obesity in the study remained nonsignificant after researchers adjusted for patient age, total motile sperm count, duration of infertility, diagnosis, source of sperm, and use of fertility medication. In addition, increased BMI had no significant impact when comparing subpopulations with and without ovulatory dysfunction.

“This is the first study evaluating effects of BMI on all women undergoing insemination in a real world scenario, regardless of diagnosis or medication used,” said Dr. Craig, an ob.gyn. specializing in reproductive endocrinology and fertility at the University of Oklahoma.

The current findings add to the limited and conflicting literature. One study, for example, found a negative effect with increasing body weight. Researchers assessed 1,144 ovulatory, married women undergoing superovulation treatment and donor insemination (Arch. Androl. 2002;48:323-7). Pregnancy rates were significantly lower as BMI increased. For example, 42% of women with a BMI of 20-24 kg/m

Another study looked at insemination of 333 ovulatory women and, similar to the current study, found no association between BMI and fecundity (Fert. Steril. 2006;86:642-6).

“To make things more confusing, Wang et al. from Australia found a positive effect of being overweight or obese in a study of 2,040 women undergoing controlled ovarian hyperstimulation and IUI,” Dr. Craig said (Fert. Ster. 2004;81:1710-2).

In contrast, there is more of a consensus among recent trials that increased BMI is associated with decreased pregnancy rates through in vitro fertilization. For example, in a study of 45,163 assisted reproduction embryo transfers in 2007, increases in obesity were associated with lower clinical pregnancy and live birth weights (Human Reprod. 2011:26:245-52). In another example, for each increase in BMI point over 29 kg/m

“My personal belief on our differences, compared [with] the ART data, is ART is not physiologically normal. Superphysiologic estradiol levels and what we do with ovarian stimulation may exacerbate the metabolic abnormalities that come out with obesity,” Dr. Craig said, “and/or we are getting these patients pregnant with less-aggressive treatment.”

Participants in the current study underwent a mean of 2.6 IUI cycles and their mean age was 33 years. There were multiple reasons for insemination, but male factor infertility was the leading indication.

During the Q & A session, the moderator asked why the lower pregnancy rate in the underweight BMI group and nearly double rate in the highest weight category were not statistically significant. Dr. Craig explained that these two categories had relatively fewer cycles (29 and 46, respectively), compared with the other groups.

A large cohort, adjustment for multiple confounders, and inclusion of almost all insemination cycles over 3 years were strengths of the study, Dr. Craig said. Only 49 cycles were excluded because the charts lacked BMI data. The retrospective design and an end point of fecundability rather than fecundity were limitations.

Fecundability is the ability or chance to conceive within a given cycle. Fecundity is chance of getting pregnant and delivering a child per cycle. So fecundity is a bit lower than fecundability because some patients will miscarry, rather than deliver, Dr. Craig said in a later interview. In the future, she would like to assess fecundity and the pregnancy rate per woman.

Dr. Craig said that she had no relevant financial disclosures.

To view a video of Dr. Craig, use the QR code or go to www.obgynnews.com

'We found no association between BMI and fecundability in women undergoing insemination.'

Source DR. CRAIG

ORLANDO – A first of its kind study shows maternal weight does not play a role in pregnancy success via intrauterine insemination, in stark contrast to multiple trials that indicate as obesity increases, the chances for a woman to conceive via in vitro fertilization drop.

“We found no association between BMI [body mass index] and fecundability in women undergoing insemination,” Dr. LaTasha B. Craig said.

She and her associates reviewed 1,120 cycles of intrauterine insemination (IUI), including donor inseminations, performed July 2007 to June 2010 at a University of Oklahoma, Oklahoma City, infertility clinic. They noted the maternal body mass index within 6 months of initiation of IUI and classified 403 women according to National Institutes of Health BMI categories.

There were 152 pregnancies. The pregnancy rate was 7% in the underweight group; 12% in the normal weight group; 15% among overweight women; 11% in the obesity class I group; 12% in the class II group; and 20% in the class III obese women. None of these differences were statistically significant.

“Obesity is increasing and, I dare say, it's pandemic now. There is probably no better place to see it in the United States now than Oklahoma,” Dr. Craig said. According to 2010 data, one-third of the state population was obese with a BMI greater than 30 kg/m

“We need information to counsel [patients] on what the realistic expectations are with obesity,” Dr. Craig said at the meeting. “It turns out there is not much information about obesity and insemination outside the PCOS [polycystic ovarian syndrome] population.”

The effect of obesity in the study remained nonsignificant after researchers adjusted for patient age, total motile sperm count, duration of infertility, diagnosis, source of sperm, and use of fertility medication. In addition, increased BMI had no significant impact when comparing subpopulations with and without ovulatory dysfunction.

“This is the first study evaluating effects of BMI on all women undergoing insemination in a real world scenario, regardless of diagnosis or medication used,” said Dr. Craig, an ob.gyn. specializing in reproductive endocrinology and fertility at the University of Oklahoma.

The current findings add to the limited and conflicting literature. One study, for example, found a negative effect with increasing body weight. Researchers assessed 1,144 ovulatory, married women undergoing superovulation treatment and donor insemination (Arch. Androl. 2002;48:323-7). Pregnancy rates were significantly lower as BMI increased. For example, 42% of women with a BMI of 20-24 kg/m

Another study looked at insemination of 333 ovulatory women and, similar to the current study, found no association between BMI and fecundity (Fert. Steril. 2006;86:642-6).

“To make things more confusing, Wang et al. from Australia found a positive effect of being overweight or obese in a study of 2,040 women undergoing controlled ovarian hyperstimulation and IUI,” Dr. Craig said (Fert. Ster. 2004;81:1710-2).

In contrast, there is more of a consensus among recent trials that increased BMI is associated with decreased pregnancy rates through in vitro fertilization. For example, in a study of 45,163 assisted reproduction embryo transfers in 2007, increases in obesity were associated with lower clinical pregnancy and live birth weights (Human Reprod. 2011:26:245-52). In another example, for each increase in BMI point over 29 kg/m

“My personal belief on our differences, compared [with] the ART data, is ART is not physiologically normal. Superphysiologic estradiol levels and what we do with ovarian stimulation may exacerbate the metabolic abnormalities that come out with obesity,” Dr. Craig said, “and/or we are getting these patients pregnant with less-aggressive treatment.”

Participants in the current study underwent a mean of 2.6 IUI cycles and their mean age was 33 years. There were multiple reasons for insemination, but male factor infertility was the leading indication.

During the Q & A session, the moderator asked why the lower pregnancy rate in the underweight BMI group and nearly double rate in the highest weight category were not statistically significant. Dr. Craig explained that these two categories had relatively fewer cycles (29 and 46, respectively), compared with the other groups.

A large cohort, adjustment for multiple confounders, and inclusion of almost all insemination cycles over 3 years were strengths of the study, Dr. Craig said. Only 49 cycles were excluded because the charts lacked BMI data. The retrospective design and an end point of fecundability rather than fecundity were limitations.

Fecundability is the ability or chance to conceive within a given cycle. Fecundity is chance of getting pregnant and delivering a child per cycle. So fecundity is a bit lower than fecundability because some patients will miscarry, rather than deliver, Dr. Craig said in a later interview. In the future, she would like to assess fecundity and the pregnancy rate per woman.

Dr. Craig said that she had no relevant financial disclosures.

To view a video of Dr. Craig, use the QR code or go to www.obgynnews.com

'We found no association between BMI and fecundability in women undergoing insemination.'

Source DR. CRAIG

ORLANDO – Short cervical length during the first trimester predicts preterm delivery of an in vitro fertilization pregnancy, according to two retrospective studies involving a total of 167 women.

Although they used slightly different parameters, researchers who assessed 113 women at Montreal Fertility Center and others who studied 54 women at Detroit Medical Center reached the same conclusion: A cervical length shorter than approximately 4 cm is associated with greater risk of delivery before 37 weeks' gestation.

These studies are part of a move to identify women at risk for preterm delivery earlier, when clinicians would have more time to intervene. Some previous researchers report associations between shorter midterm cervical length and preterm delivery (Ultrasound Obstet. Gynecol. 2008;32:640-5), while others point to a need for additional evidence (Cochrane Database Syst. Rev. 2009;CD007235 [doi:10.1002/14651858.CD007235.pub2]).

“Little is known about the predictive value of a first-trimester cervical length measurement,” Dr. Olivia Vincent-Boulay of the Montreal Fertility Centre said at the meeting.

Dr. Vincent-Boulay and her associates reviewed transvaginal ultrasound findings for 113 women who conceived via in vitro fertilization (IVF) at their center. Cervical length measurements were taken between 6 and 12 weeks' gestation. A total 60% delivered full term, at 37 weeks or longer. Another 23% delivered at 34-36 weeks; 10% at 30-33 weeks; and 7% of women delivered before 30 weeks' gestation. Thus, 40% delivered prior to 37 weeks' gestation.

As their average first-trimester cervical length decreased, so did mean gestational age. For example, women with a cervix of 5 cm or longer delivered at a mean of 37 weeks. This decreased to 35 weeks for those with a cervical length from 4.0 cm to 4.9 cm and to 32 weeks for mothers with a cervix shorter than 4.0 cm.

“Our sample size was pretty small, which is why we chose 5-cm and below 4-cm groups,” Dr. Vincent-Boulay said. “It would be great to do further studies with a larger sample to do a more stratified analysis.”

There were some interesting differences between the 86 singleton and 27 twin pregnancies. Cervical length below 5 cm during the first trimester significantly correlated with preterm delivery in twin pregnancies. In the case of singletons, only a measurement below 4 cm was a significant predictor. The researchers assessed serial ultrasound measurements, and found, for example, that cervical length at 10 weeks predicted a preterm delivery of twins but not singletons.

Of the 113 IVF pregnancies, 86 or (76%) were singletons and 27 (24%) were twins. A greater number of singletons were delivered at full term (58 children), compared with twins (10 sets) in the study.

Put into clinical terms, Dr. Vincent-Boulay said: “Less than 4 cm at any time during pregnancy, whether it is single or twins, may be a cause for alarm. A cervical length less than 5 cm at 10 weeks for twins is also significant risk for preterm delivery.”

A second study presented at the ASRM meeting revealed a very similar cervical length cutoff during the first trimester, 38.5 mm (or 3.85 cm) or less. Dr. Zain Al-Safi and his colleagues reviewed the records for 54 women who conceived via IVF at Wayne State University/Detroit Medical Center.

Specifically, they found 17 or 32% of pregnant women with a short cervical length measured at the first ultrasound (between 5 and 9 weeks' gestation) delivered before 37 weeks' gestation. Fifteen women who delivered preterm had an ultrasound measurement of 38.5 mm or less, giving this cutoff a sensitivity of 47% and a specificity of 81%.

This study is important because “premature delivery is a major obstetric complication and a substantial contributor to neonatal morbidity,” said Dr. Al-Safi, an ob.gyn. at Wayne State University.

A total 21 women (39%) had multiple gestations. A meeting attendee commented that this was a high percentage and asked about IVF embryo transfer protocol.

“We did not include that in our results. We looked at twins, but did not go back and look at how many embryos were transferred,” Dr. Al-Safi replied.

A follow-up question was asked about the findings without multiples. “We took out multiples and frozen embryos and found similar results,” Dr. Al-Safi said.

A lack of follow-up ultrasound assessment in the second trimester, a small sample size, and the retrospective design are potential limitations, Dr. Al-Safi said. The findings should be considered experimental until replicated in larger, prospective studies, he added.

“If we know cervical length in the future correlates to preterm delivery … we could prevent it,” Dr. Al-Safi said.

Future studies also should evaluate the optimal management for patients with a short cervix, Dr. Vincent-Boulay said.

ORLANDO – Short cervical length during the first trimester predicts preterm delivery of an in vitro fertilization pregnancy, according to two retrospective studies involving a total of 167 women.

Although they used slightly different parameters, researchers who assessed 113 women at Montreal Fertility Center and others who studied 54 women at Detroit Medical Center reached the same conclusion: A cervical length shorter than approximately 4 cm is associated with greater risk of delivery before 37 weeks' gestation.

These studies are part of a move to identify women at risk for preterm delivery earlier, when clinicians would have more time to intervene. Some previous researchers report associations between shorter midterm cervical length and preterm delivery (Ultrasound Obstet. Gynecol. 2008;32:640-5), while others point to a need for additional evidence (Cochrane Database Syst. Rev. 2009;CD007235 [doi:10.1002/14651858.CD007235.pub2]).

“Little is known about the predictive value of a first-trimester cervical length measurement,” Dr. Olivia Vincent-Boulay of the Montreal Fertility Centre said at the meeting.

Dr. Vincent-Boulay and her associates reviewed transvaginal ultrasound findings for 113 women who conceived via in vitro fertilization (IVF) at their center. Cervical length measurements were taken between 6 and 12 weeks' gestation. A total 60% delivered full term, at 37 weeks or longer. Another 23% delivered at 34-36 weeks; 10% at 30-33 weeks; and 7% of women delivered before 30 weeks' gestation. Thus, 40% delivered prior to 37 weeks' gestation.

As their average first-trimester cervical length decreased, so did mean gestational age. For example, women with a cervix of 5 cm or longer delivered at a mean of 37 weeks. This decreased to 35 weeks for those with a cervical length from 4.0 cm to 4.9 cm and to 32 weeks for mothers with a cervix shorter than 4.0 cm.

“Our sample size was pretty small, which is why we chose 5-cm and below 4-cm groups,” Dr. Vincent-Boulay said. “It would be great to do further studies with a larger sample to do a more stratified analysis.”

There were some interesting differences between the 86 singleton and 27 twin pregnancies. Cervical length below 5 cm during the first trimester significantly correlated with preterm delivery in twin pregnancies. In the case of singletons, only a measurement below 4 cm was a significant predictor. The researchers assessed serial ultrasound measurements, and found, for example, that cervical length at 10 weeks predicted a preterm delivery of twins but not singletons.

Of the 113 IVF pregnancies, 86 or (76%) were singletons and 27 (24%) were twins. A greater number of singletons were delivered at full term (58 children), compared with twins (10 sets) in the study.

Put into clinical terms, Dr. Vincent-Boulay said: “Less than 4 cm at any time during pregnancy, whether it is single or twins, may be a cause for alarm. A cervical length less than 5 cm at 10 weeks for twins is also significant risk for preterm delivery.”

A second study presented at the ASRM meeting revealed a very similar cervical length cutoff during the first trimester, 38.5 mm (or 3.85 cm) or less. Dr. Zain Al-Safi and his colleagues reviewed the records for 54 women who conceived via IVF at Wayne State University/Detroit Medical Center.

Specifically, they found 17 or 32% of pregnant women with a short cervical length measured at the first ultrasound (between 5 and 9 weeks' gestation) delivered before 37 weeks' gestation. Fifteen women who delivered preterm had an ultrasound measurement of 38.5 mm or less, giving this cutoff a sensitivity of 47% and a specificity of 81%.

This study is important because “premature delivery is a major obstetric complication and a substantial contributor to neonatal morbidity,” said Dr. Al-Safi, an ob.gyn. at Wayne State University.

A total 21 women (39%) had multiple gestations. A meeting attendee commented that this was a high percentage and asked about IVF embryo transfer protocol.

“We did not include that in our results. We looked at twins, but did not go back and look at how many embryos were transferred,” Dr. Al-Safi replied.

A follow-up question was asked about the findings without multiples. “We took out multiples and frozen embryos and found similar results,” Dr. Al-Safi said.

A lack of follow-up ultrasound assessment in the second trimester, a small sample size, and the retrospective design are potential limitations, Dr. Al-Safi said. The findings should be considered experimental until replicated in larger, prospective studies, he added.

“If we know cervical length in the future correlates to preterm delivery … we could prevent it,” Dr. Al-Safi said.

Future studies also should evaluate the optimal management for patients with a short cervix, Dr. Vincent-Boulay said.

ORLANDO – Short cervical length during the first trimester predicts preterm delivery of an in vitro fertilization pregnancy, according to two retrospective studies involving a total of 167 women.

Although they used slightly different parameters, researchers who assessed 113 women at Montreal Fertility Center and others who studied 54 women at Detroit Medical Center reached the same conclusion: A cervical length shorter than approximately 4 cm is associated with greater risk of delivery before 37 weeks' gestation.

These studies are part of a move to identify women at risk for preterm delivery earlier, when clinicians would have more time to intervene. Some previous researchers report associations between shorter midterm cervical length and preterm delivery (Ultrasound Obstet. Gynecol. 2008;32:640-5), while others point to a need for additional evidence (Cochrane Database Syst. Rev. 2009;CD007235 [doi:10.1002/14651858.CD007235.pub2]).

“Little is known about the predictive value of a first-trimester cervical length measurement,” Dr. Olivia Vincent-Boulay of the Montreal Fertility Centre said at the meeting.

Dr. Vincent-Boulay and her associates reviewed transvaginal ultrasound findings for 113 women who conceived via in vitro fertilization (IVF) at their center. Cervical length measurements were taken between 6 and 12 weeks' gestation. A total 60% delivered full term, at 37 weeks or longer. Another 23% delivered at 34-36 weeks; 10% at 30-33 weeks; and 7% of women delivered before 30 weeks' gestation. Thus, 40% delivered prior to 37 weeks' gestation.

As their average first-trimester cervical length decreased, so did mean gestational age. For example, women with a cervix of 5 cm or longer delivered at a mean of 37 weeks. This decreased to 35 weeks for those with a cervical length from 4.0 cm to 4.9 cm and to 32 weeks for mothers with a cervix shorter than 4.0 cm.

“Our sample size was pretty small, which is why we chose 5-cm and below 4-cm groups,” Dr. Vincent-Boulay said. “It would be great to do further studies with a larger sample to do a more stratified analysis.”

There were some interesting differences between the 86 singleton and 27 twin pregnancies. Cervical length below 5 cm during the first trimester significantly correlated with preterm delivery in twin pregnancies. In the case of singletons, only a measurement below 4 cm was a significant predictor. The researchers assessed serial ultrasound measurements, and found, for example, that cervical length at 10 weeks predicted a preterm delivery of twins but not singletons.

Of the 113 IVF pregnancies, 86 or (76%) were singletons and 27 (24%) were twins. A greater number of singletons were delivered at full term (58 children), compared with twins (10 sets) in the study.

Put into clinical terms, Dr. Vincent-Boulay said: “Less than 4 cm at any time during pregnancy, whether it is single or twins, may be a cause for alarm. A cervical length less than 5 cm at 10 weeks for twins is also significant risk for preterm delivery.”

A second study presented at the ASRM meeting revealed a very similar cervical length cutoff during the first trimester, 38.5 mm (or 3.85 cm) or less. Dr. Zain Al-Safi and his colleagues reviewed the records for 54 women who conceived via IVF at Wayne State University/Detroit Medical Center.

Specifically, they found 17 or 32% of pregnant women with a short cervical length measured at the first ultrasound (between 5 and 9 weeks' gestation) delivered before 37 weeks' gestation. Fifteen women who delivered preterm had an ultrasound measurement of 38.5 mm or less, giving this cutoff a sensitivity of 47% and a specificity of 81%.

This study is important because “premature delivery is a major obstetric complication and a substantial contributor to neonatal morbidity,” said Dr. Al-Safi, an ob.gyn. at Wayne State University.

A total 21 women (39%) had multiple gestations. A meeting attendee commented that this was a high percentage and asked about IVF embryo transfer protocol.

“We did not include that in our results. We looked at twins, but did not go back and look at how many embryos were transferred,” Dr. Al-Safi replied.

A follow-up question was asked about the findings without multiples. “We took out multiples and frozen embryos and found similar results,” Dr. Al-Safi said.

A lack of follow-up ultrasound assessment in the second trimester, a small sample size, and the retrospective design are potential limitations, Dr. Al-Safi said. The findings should be considered experimental until replicated in larger, prospective studies, he added.

“If we know cervical length in the future correlates to preterm delivery … we could prevent it,” Dr. Al-Safi said.

Future studies also should evaluate the optimal management for patients with a short cervix, Dr. Vincent-Boulay said.

ORLANDO – Obesity puts a mom-to-be at greater risk for adverse pregnancy outcomes when she conceives through in vitro fertilization, according to a meta-analysis.

Significantly lower clinical pregnancy rates, a higher miscarriage risk, and lower live birth rates are each more likely when the body mass index (BMI) of a mother is greater than 30 kg/m², compared with normal weight mothers, according to a study presented at the annual meeting of the American Society for Reproductive Medicine.

Although previous researchers assessed BMI in women undergoing in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), "the effect of obesity on IVF and ICSI remains unclear," Dr. Hassan Sallam said. "Some studies have found negative associations while others have not confirmed it."

Researchers who performed a previous systematic review of the literature cited "insufficient evidence" for any significant link between a higher BMI and IVF pregnancy outcomes (Hum. Reprod. Update 2007;13:433-44).

In search of a more definitive answer, Dr. Sallam and his colleagues decided to update the 2007 meta-analysis. With inclusion of more recent studies, obesity was associated with significantly worse pregnancy outcomes compared with women with a normal BMI (20-25) undergoing assisted reproduction. The current meta-analysis includes data from 15 controlled studies.

Six studies reported live birth rates, the primary outcome of the meta-analysis. Dr. Sallam and his associates found a live birth rate of 23% among obese women and 25% among normal weight controls, a statistically significantly difference (odds ratio, 0.85).

"Obese women undergoing IVF and ICSI have significant lower live birth rates and clinical pregnancy rates," said Dr. Sallam, professor of obstetrics and gynecology at the University of Alexandria in Egypt.

Of the eight studies that reported clinical pregnancy rates, 40.5% of obese women achieved pregnancy, compared with 43.8% of controls, also a statistically significant difference (OR, 0.88).

Obese participants also experienced significantly higher cancellation and miscarriage rates, Dr. Sallam said. In obese women, the cancellation rate was 8.7%, compared with 6.5% in controls (OR, 1.40). Miscarriages occurred in 21.9% of obese women vs. 19.3% of normal controls (OR, 1.22). Each of these factors was reported in five studies.

Not all outcomes were significantly different between obese and normal weight women. For example, 20.9% of obese women vs. 20.5% of controls achieved embryo implantation (OR, 1.03). The proportion of multiple pregnancies, likewise, was not statistically different: 21.5% of obese women versus 26.9% of controls (OR, 0.90). Dr. Sallam noted that only two studies each reported these outcomes.

"Whether obese women should be denied IVF ... is an open question," Dr. Sallam said. He cited a report from researchers who examined whether certain lifestyle changes should be mandated prior to IVF (Human Reprod. 2010;25:578-83). They specifically examined whether women at higher risk for poor outcomes due to obesity and alcohol or tobacco consumption should be required to make changes prior to receipt of assisted reproductive technology.

Dr. Sallam said he and his coauthors had no relevant financial disclosures.

ORLANDO – Obesity puts a mom-to-be at greater risk for adverse pregnancy outcomes when she conceives through in vitro fertilization, according to a meta-analysis.

Significantly lower clinical pregnancy rates, a higher miscarriage risk, and lower live birth rates are each more likely when the body mass index (BMI) of a mother is greater than 30 kg/m², compared with normal weight mothers, according to a study presented at the annual meeting of the American Society for Reproductive Medicine.

Although previous researchers assessed BMI in women undergoing in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), "the effect of obesity on IVF and ICSI remains unclear," Dr. Hassan Sallam said. "Some studies have found negative associations while others have not confirmed it."

Researchers who performed a previous systematic review of the literature cited "insufficient evidence" for any significant link between a higher BMI and IVF pregnancy outcomes (Hum. Reprod. Update 2007;13:433-44).

In search of a more definitive answer, Dr. Sallam and his colleagues decided to update the 2007 meta-analysis. With inclusion of more recent studies, obesity was associated with significantly worse pregnancy outcomes compared with women with a normal BMI (20-25) undergoing assisted reproduction. The current meta-analysis includes data from 15 controlled studies.

Six studies reported live birth rates, the primary outcome of the meta-analysis. Dr. Sallam and his associates found a live birth rate of 23% among obese women and 25% among normal weight controls, a statistically significantly difference (odds ratio, 0.85).

"Obese women undergoing IVF and ICSI have significant lower live birth rates and clinical pregnancy rates," said Dr. Sallam, professor of obstetrics and gynecology at the University of Alexandria in Egypt.

Of the eight studies that reported clinical pregnancy rates, 40.5% of obese women achieved pregnancy, compared with 43.8% of controls, also a statistically significant difference (OR, 0.88).

Obese participants also experienced significantly higher cancellation and miscarriage rates, Dr. Sallam said. In obese women, the cancellation rate was 8.7%, compared with 6.5% in controls (OR, 1.40). Miscarriages occurred in 21.9% of obese women vs. 19.3% of normal controls (OR, 1.22). Each of these factors was reported in five studies.

Not all outcomes were significantly different between obese and normal weight women. For example, 20.9% of obese women vs. 20.5% of controls achieved embryo implantation (OR, 1.03). The proportion of multiple pregnancies, likewise, was not statistically different: 21.5% of obese women versus 26.9% of controls (OR, 0.90). Dr. Sallam noted that only two studies each reported these outcomes.

"Whether obese women should be denied IVF ... is an open question," Dr. Sallam said. He cited a report from researchers who examined whether certain lifestyle changes should be mandated prior to IVF (Human Reprod. 2010;25:578-83). They specifically examined whether women at higher risk for poor outcomes due to obesity and alcohol or tobacco consumption should be required to make changes prior to receipt of assisted reproductive technology.

Dr. Sallam said he and his coauthors had no relevant financial disclosures.

ORLANDO – Obesity puts a mom-to-be at greater risk for adverse pregnancy outcomes when she conceives through in vitro fertilization, according to a meta-analysis.

Significantly lower clinical pregnancy rates, a higher miscarriage risk, and lower live birth rates are each more likely when the body mass index (BMI) of a mother is greater than 30 kg/m², compared with normal weight mothers, according to a study presented at the annual meeting of the American Society for Reproductive Medicine.

Although previous researchers assessed BMI in women undergoing in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), "the effect of obesity on IVF and ICSI remains unclear," Dr. Hassan Sallam said. "Some studies have found negative associations while others have not confirmed it."

Researchers who performed a previous systematic review of the literature cited "insufficient evidence" for any significant link between a higher BMI and IVF pregnancy outcomes (Hum. Reprod. Update 2007;13:433-44).

In search of a more definitive answer, Dr. Sallam and his colleagues decided to update the 2007 meta-analysis. With inclusion of more recent studies, obesity was associated with significantly worse pregnancy outcomes compared with women with a normal BMI (20-25) undergoing assisted reproduction. The current meta-analysis includes data from 15 controlled studies.

Six studies reported live birth rates, the primary outcome of the meta-analysis. Dr. Sallam and his associates found a live birth rate of 23% among obese women and 25% among normal weight controls, a statistically significantly difference (odds ratio, 0.85).

"Obese women undergoing IVF and ICSI have significant lower live birth rates and clinical pregnancy rates," said Dr. Sallam, professor of obstetrics and gynecology at the University of Alexandria in Egypt.

Of the eight studies that reported clinical pregnancy rates, 40.5% of obese women achieved pregnancy, compared with 43.8% of controls, also a statistically significant difference (OR, 0.88).

Obese participants also experienced significantly higher cancellation and miscarriage rates, Dr. Sallam said. In obese women, the cancellation rate was 8.7%, compared with 6.5% in controls (OR, 1.40). Miscarriages occurred in 21.9% of obese women vs. 19.3% of normal controls (OR, 1.22). Each of these factors was reported in five studies.

Not all outcomes were significantly different between obese and normal weight women. For example, 20.9% of obese women vs. 20.5% of controls achieved embryo implantation (OR, 1.03). The proportion of multiple pregnancies, likewise, was not statistically different: 21.5% of obese women versus 26.9% of controls (OR, 0.90). Dr. Sallam noted that only two studies each reported these outcomes.

"Whether obese women should be denied IVF ... is an open question," Dr. Sallam said. He cited a report from researchers who examined whether certain lifestyle changes should be mandated prior to IVF (Human Reprod. 2010;25:578-83). They specifically examined whether women at higher risk for poor outcomes due to obesity and alcohol or tobacco consumption should be required to make changes prior to receipt of assisted reproductive technology.

Dr. Sallam said he and his coauthors had no relevant financial disclosures.