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Have PCOS and want a baby?

Trial Status: Open for Enrollment

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What is the purpose of this study?

This is a three-armed randomized study to establish the relative roles of treatment of hyperandrogenism versus obesity in treating infertility and improving pregnancy outcomes among obese PCOS women. Phase I of this study will be a randomized trial of three interventions in infertile women with PCOS. The first arm will be a combined intervention of Orlistat (brand name Alli) medication, meal replacements, and lifestyle modification to improve insulin resistance. Orlistat is a medication that inhibits the gastrointestinal absorption of fat. The second arm will be the use of a continuous oral contraceptive pill, Lo-Estrin, for 4 months to improve hyperandrogenism. The third arm is the combination of the first and second arms, to improve both hyperandrogenism and insulin resistance. Phase II of this study will involve 4 cycles of ovulation induction with Clomiphene citrate with hopeful outcome of pregnancy. Finally, Phase III will involve following the pregnancies for outcomes and complications.