Carolinas HealthCare System

Carolinas HealthCare System Physician Helps Discover Infertility Breakthrough

Rebecca S. Usadi, MD
Associate Director of the System’s Reproductive Medicine and Infertility

A Carolinas HealthCare System physician has helped prove a more effective way of treating women with polycystic ovary syndrome (PCOS), a hormone imbalance condition that can interfere with normal ovulation.

More than six million women in the United States are diagnosed with PCOS each year, the most common hormonal abnormality in reproductive-age women and a leading cause of infertility.

A groundbreaking, multicenter clinical study, under the direction of Rebecca S. Usadi, MD, associate director of the System’s Reproductive Medicine and Infertility, has proven that the standard treatment of helping women with PCOS to get pregnant is not the most effective. The new treatment is a better way to improve the likelihood of a woman getting pregnant and delivering a healthy baby.
Historically, women with PCOS have been prescribed a drug called clomiphene to help them get pregnant. Clomiphene 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 and  does not have a very high success rate for live births – just 22 percent – while tending to lead to a high number of twins or multiple pregnancies.

“The Reproductive Medicine Network has been determined to find a better way to treat patients with PCOS,” Dr. Usadi said. “Now, 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.”

That drug is letrozole, an aromatase inhibitor which is FDA approved for breast cancer treatment, and 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.

The study launched in 2009 to test the effectiveness of letrozole and clomiphene in treating PCOS-related infertility over a five-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 percent versus 19 percent). Letrozole also led to significantly increased ovulation rates and decreased hot flashes.

“This is a big milestone for women with PCOS. We will now offer a more effective treatment for our patients desiring to get pregnant,” said Robert Higgins, MD, interim chair and residency program director, department of OB/GYN at Carolinas HealthCare System. “The results of this research will change the care of women with this disease.”

The study was funded in part by 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.