Women's Health Ben Brown | 3 years ago

Study Proves Most Effective Drug for Common Infertility Syndrome in Women

Rebecca S. Usadi, MD, associate director of Carolinas HealthCare System’s Reproductive Medicine and Infertility team, helps prove that a new drug increases live birth rate for women with a leading cause of infertility.

Over six million women in the United States are diagnosed with polycystic ovary syndrome (PCOS), the most common hormonal abnormality in reproductive age women and a leading cause of infertility. PCOS is a hormone imbalance condition that can interfere with normal ovulation. A groundbreaking new study has proven that the standard treatment of helping women with PCOS to get pregnant is not the most effective- and that there is a better way to improve the likelihood of them getting pregnant and delivering a healthy baby. Historically, women with PCOS have been prescribed a drug called clomiphene to help them get pregnant. It can stimulate ovulation in a woman who does not ovulate or who ovulates irregularly. However, the drug has multiple negative side effects, including hot flashes and mood changes. In addition, the drug does not have a very high success rate for live births- just 22 percent- and it tends to lead to a high number of twin or multiple pregnancies. “The Reproductive Medicine Network has been determined to find a better way to treat patients with PCOS,” Rebecca S. Usadi, MD, associate director of Carolinas HealthCare System’s Reproductive Medicine and Infertility team said. “I’m thrilled to announce that we have proven that there is another drug that is more effective than clomiphene in regulating ovulation and increasing the chances of having a baby.” Letrozole, an aromatase inhibitor which is FDA approved for breast cancer treatment has been used in an off-label fashion to stimulate ovulation for a little over a decade. . The drug can suppress production of estrogen, which in turn triggers release of the hormones that drive ovulation. Physicians looked to this drug as a possible alternative to clomiphene when exploring a better option to treat infertility with PCOS. A multicenter clinical study, involving Carolinas HealthCare System under the direction of Dr. Usadi, was launched in 2009 to test the effectiveness of letrozole and clomiphene in treating PCOS-related infertility over a 5 month period. The researchers enrolled 750 infertile women with PCOS who were between 18 and 40 years of age. The study found that women treated with letrozole were more likely to have live births than those receiving clomiphene (cumulative rate 28% vs. 19%). Letrozole also led to significantly increased ovulation rates and decreased hot flashes compared with clomiphene. “This is a big milestone for women with PCOS- we will now offer a more effective treatment for our patients desiring to get pregnant,” Robert Higgins, MD, interim chair and residency program director, department of Ob/Gyn at Carolinas HealthCare System, said. “The results of this research will change the care of women with this disease.” The study was funded in part by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. Results were published on July 10, 2014, in the New England Journal of Medicine.   1200483

Rebecca Usadi, MD is a OB/GYN and associate director of  Carolinas HealthCare System's Reproductive Medicine and Infertility team.