• Richard S Legro, William C Dodson, Penny M Kris-Etherton, Allen R Kunselman, Christy M Stetter, Nancy I Williams, Carol L Gnatuk, Stephanie J Estes, Jennifer Fleming, Kelly C Allison, David B Sarwer, Christos Coutifaris, and Anuja Dokras.
• Departments of Obstetrics and Gynecology (R.S.L., W.C.D., C.L.G., S.J.E.) and Public Health Sciences (R.S.L., A.R.K., C.M.S.), Penn State College of Medicine, Hershey, PA, Departments of Nutritional Sciences (P.M.K., J.F.) and Kinesiology (N.I.W.), Penn State College of Health and Human Development, University Park, Pennsylvania 16802; and Departments of Psychiatry (D.B.S., K.C.A.), Surgery (D.B.S.), and Obstetrics and Gynecology (A.D., C.C.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania 19104.
• J. Clin. Endocrinol. Metab. 2015 Nov 1; 100 (11): 4048-58.

ContextLifestyle modification is recommended in women with polycystic ovary syndrome (PCOS) prior to conception but there are few randomized trials to support its implementation or benefit.ObjectiveThis study aimed to determine the relative efficacy of preconception intervention on reproductive and metabolic abnormalities in overweight/obese women with PCOS.Design, Setting, And ParticipantsThis was a randomized controlled trial of preconception and infertility treatment at Academic Health Centers in women with infertility due to PCOS, age 18-40 y and body mass index 27-42 kg/m(2).InterventionWomen were randomly assigned to receive either 16 weeks of 1) continuous oral contraceptive pills (OCPs) (ethinyl estradiol 20 mcg/1 mg norethindrone acetate) ("OCP"); 2) lifestyle modification consisting of caloric restriction with meal replacements, weight loss medication (either sibutramine, or orlistat), and increased physical activity to promote a 7% weight loss ("Lifestyle"); or 3) combined treatment with both OCP and lifestyle modification ("Combined"). After preconception intervention, women underwent standardized ovulation induction with clomiphene citrate and timed intercourse for four cycles. Pregnancies were followed with trimester visits until delivery.Main Outcome MeasuresWeight, ovulation, and live birth were measured.ResultsWe consented 216 and randomly assigned 149 women (Lifestyle: n = 50; OCP: n = 49; Combined: n = 50). We achieved significant weight loss with both Lifestyle (mean weight loss, -6.2%; 95% confidence interval (CI), -7.4--5.0; and Combined (mean weight loss, -6.4%; 95% CI, -7.6--5.2) compared with baseline and OCP (both P < .001). There was a significant increase in the prevalence of metabolic syndrome at the end of preconception treatment compared with baseline within OCP (odds ratio [OR, 2.47; 95% CI, 1.42-4.27) whereas no change in metabolic syndrome was detected in the Lifestyle (OR, 1.18; 95% CI, 0.63-2.19) or Combined (OR, 0.72; 95% CI, 0.44-1.17) groups. Cumulative ovulation rates were superior after weight loss: OCP, 46%; Lifestyle, 60%; and Combined, 67% (P < .05). Live birth rates were OCP, 12%; Lifestyle, 26%; and Combined, 24% (P = .13).ConclusionsA preconception weight loss intervention eliminates the adverse metabolic oral contraceptive effects and, compared with oral contraceptive pretreatment, leads to higher ovulation rates.

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