title: The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial.
abstract: OBJECTIVE
  To summarize baseline characteristics from a large multicenter infertility clinical trial.
  
  
  METHODS
  Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene).
  
  
  METHODS
  Academic Health Centers throughout the United States.
  
  
  METHODS
  Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study.
  
  
  METHODS
  None.
  
  
  METHODS
  Historic, biometric, biochemical, and questionnaire parameters.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT00719186.
authors.affiliation: Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania. Electronic address: RSL1@PSU.EDU.
authors.forename: Richard S
authors.initials: RS
authors.lastname: Legro
authors.affiliation: Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, Texas.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Brzyski
authors.affiliation: Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Diamond
authors.affiliation: Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Christos
authors.initials: C
authors.lastname: Coutifaris
authors.affiliation: Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.
authors.forename: William D
authors.initials: WD
authors.lastname: Schlaff
authors.affiliation: Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.
authors.forename: Ruben
authors.initials: R
authors.lastname: Alvero
authors.affiliation: Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont.
authors.forename: Peter
authors.initials: P
authors.lastname: Casson
authors.affiliation: Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Christman
authors.affiliation: Department of Biostatistics, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Hao
authors.initials: H
authors.lastname: Huang
authors.affiliation: Department of Biostatistics, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Qingshang
authors.initials: Q
authors.lastname: Yan
authors.affiliation: Ligand Core Laboratory University of Virginia Center for Research in Reproduction, Charlottesville, Virginia.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Haisenleder
authors.affiliation: Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Kurt T
authors.initials: KT
authors.lastname: Barnhart
authors.affiliation: Department of Obstetrics and Gynecology, University of Alabama, Birmingham, Alabama.
authors.forename: G Wright
authors.initials: GW
authors.lastname: Bates
authors.affiliation: Department of Obstetrics and Gynecology, Carolinas HealthCare Center for Reproductive Medicine, Charlotte, North Carolina.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Usadi
authors.affiliation: Department of Obstetrics and Gynecology, Virginia Commonwealth University, Richmond, Virginia.
authors.forename: Richard
authors.initials: R
authors.lastname: Lucidi
authors.affiliation: Department of Obstetrics and Gynecology, Stanford Hospital, Palo Alto, California.
authors.forename: Valerie
authors.initials: V
authors.lastname: Baker
authors.affiliation: Urology, SUNY Upstate Medical University, Syracuse, New York.
authors.forename: J C
authors.initials: JC
authors.lastname: Trussell
authors.affiliation: Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Krawetz
authors.affiliation: Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Peter
authors.initials: P
authors.lastname: Snyder
authors.affiliation: Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan.
authors.forename: Dana
authors.initials: D
authors.lastname: Ohl
authors.affiliation: Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.
authors.forename: Nanette
authors.initials: N
authors.lastname: Santoro
authors.affiliation: Fertility and Infertility Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Rockville, Maryland.
authors.forename: Esther
authors.initials: E
authors.lastname: Eisenberg
authors.affiliation: Department of Biostatistics, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Heping
authors.initials: H
authors.lastname: Zhang
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005300:Fertility Agents, Female / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D008297:Male; D009765:Obesity / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology*; D011085:Polycystic Ovary Syndrome / Q000175:diagnosis* / Q000188:drug therapy / Q000453:epidemiology*; D011247:Pregnancy / Q000187:drug effects; D055815:Young Adult
chemical_list: D005300:Fertility Agents, Female
keywords: Insulin resistance; hirsutism; infertility; metabolic syndrome; ovulation induction