The Pregnancy in Polycystic Ovary Syndrome Study II baseline characteristics and effects of obesity from a multicenter randomized clinical trial

Baseline characteristics from 750 women with PCOS and their male partners from a multicenter trial show the groups to be well matched with body mass index exacerbating metabolic and reproductive parameters.

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Richard S. Legro, M.D., Robert G. Brzyski, M.D., Ph.D., Michael P. Diamond, M.D., Christos Coutifaris, M.D., Ph.D., William D. Schlaff, M.D., Ruben Alvero, M.D., Peter Casson, M.D., Gregory M. Christman, M.D., Hao Huang, M.D., M.P.H., Qingshang Yan, Ph.D., Daniel J. Haisenleder, Ph.D., Kurt T. Barnhart, M.D., G. Wright Bates, M.D., Rebecca Usadi, M.D., Richard Lucidi, M.D., Valerie Baker, M.D., J.C. Trussell, M.D., Stephen A. Krawetz, Ph.D., Peter Snyder, M.D., Dana Ohl, M.D., Nanette Santoro, M.D., Esther Eisenberg, M.D., M.P.H., Heping Zhang, Ph.D., for the NICHD Reproductive Medicine Network

Volume 101, Issue 1, Pages 258-269.e8, January 2014



To summarize baseline characteristics from a large multicenter infertility clinical trial.


Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene).


Academic Health Centers throughout the United States.


Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study.



Main Outcome Measure(s):

Historic, biometric, biochemical, and questionnaire parameters.


Females averaged 30 years and were obese (body mass index [BMI] 35) with ∼20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). Most of the women had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH-to-FSH ratio (∼2), and antimüllerian hormone levels (8.0 ng/mL). In addition, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH-to-FSH levels, antimüllerian hormone levels, and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Men were obese (BMI 30) and had normal mean semen parameters.


The treatment groups were well matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators.

Clinical Trial Registration Number:


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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders.