Metformin, a drug used to treat diabetes and thought to hold great promise at overcoming the infertility associated with polycystic// ovary syndrome (PCOS), is less useful for helping women with the condition achieve pregnancy than is the standard treatment with the infertility drug clomiphene, report researchers in an NIH research network.

This study is the largest, most comprehensive effort yet to compare the two drugs in helping women with PCOS achieve successful pregnancy.

“The results of this study underscore the need to test any new treatment rigorously, no matter how promising it may seem initially,” said Duane Alexander, M.D., Director of the National Institute of Child Health and Human Development, which supported the study, along with the National Center for Research Resources. Both NICHD and NCRR are part of NIH.

Polycystic ovary syndrome (PCOS) affects seven to eight percent of women in the United States and may be the most common cause of female infertility, the study authors wrote. With PCOS, an excess of male hormones interferes with ovulation. The ovaries become enlarged and fill with cysts. In addition to infertility, PCOS symptoms include irregular menstrual periods, excessive body and facial hair, acne, and obesity.

Women with PCOS frequently experience insulin resistance, a prediabetic condition in which higher-than-normal amounts of insulin are required to allow glucose to enter tissues. Earlier studies had shown that drugs such as metformin, which make the body more sensitive to insulin, could increase ovulation in PCOS patients. Similarly, several smaller studies had suggested that metformin, alone or when taken together with the drug clomiphene, could result in greater fertility rates for PCOS patients than could clomiphene taken alone. Clomiphene fosters ovulation by stimulating the release of hormones needed for ovulation to occur.

To conduct the study, the researchers randomly ass
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