The pregnancy in polycystic ovary syndrome II study: Baseline characteristics and effects of obesity from a multicenter randomized clinical trial

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

Research output: Contribution to journalArticle

28 Scopus citations


Objective To summarize baseline characteristics from a large multicenter infertility clinical trial. Design Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene). Setting Academic Health Centers throughout the United States. Patient(s) Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study. Intervention(s) None. Main Outcome Measure(s) Historic, biometric, biochemical, and questionnaire parameters. Result(s) 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. Conclusion(s) 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 NCT00719186.

Original languageEnglish (US)
JournalFertility and sterility
Issue number1
Publication statusPublished - Jan 1 2014



  • Insulin resistance
  • hirsutism
  • infertility
  • metabolic syndrome
  • ovulation induction

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this