Although current data suggest that metformin increases the frequency of spontaneous ovulation and improves the efficacy of ovulation induction and clinical pregnancy with clomiphene, large-scale studies with metformin have not been completed. Hence, the optimal therapy or combination of therapies to achieve pregnancy most efficiently is currently unknown. If pregnancy is desired as soon as possible, currently clomiphene is still the historical standard of care until larger-scale studies have been completed. If ovulation induction is not successful with clomiphene or if the establishment of pregnancy is difficult despite successful ovulation induction with clomiphene, current data suggest that the addition of metformin is the logical next step.
In the scenario where a woman with PCOS desires pregnancy but time to achieving pregnancy is not of essence, current evidence suggests it would be reasonable to use metformin as an initial therapy combined with lifestyle intervention. If metformin therapy is not successful in increasing ovulation, clomiphene should be added to metformin therapy. While waiting for the results of prospective randomized studies, the addition of metformin may be beneficial for the establishment and maintenance of pregnancy in women with PCOS who have a prior history of spontaneous abortions after conceiving with clomiphene.
In order to establish the optimal therapy or combination of therapies to achieve pregnancy most efficiently, the National Institutes of Health's Reproductive Medicine Network is conducting the Pregnancy in Polycystic Ovary Syndrome (PPCOS) study. The PPCOS study is a randomized, doubleblind controlled trial comparing three regimens in women with PCOS desiring pregnancy: (a) monotherapy with extended-release metformin (metformin XR), (b) clomiphene citrate monotherapy, and (c) a combination of metformin XR and clomiphene citrate. In addition to the usual inclusion criteria for PCOS women (elevated serum testosterone and eight or fewer menstrual cycles per year), partners of these women with PCOS must have normal sperm counts, and the enrolled subjects must agree to have intercourse two to three times per week during the study. The primary endpoint is the number of live births. Thirteen U.S. centers are participating in the clinical trial, and enrollment for this study has been completed and totals more than 600 women. Results of this study are eagerly awaited and will define the best initial treatment for women with PCOS desiring pregnancy.
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