title: The Pregnancy in Polycystic Ovary Syndrome study: baseline characteristics of the randomized cohort including racial effects.
abstract: OBJECTIVE
  To report the baseline characteristics and racial differences in the polycystic ovary syndrome (PCOS) phenotype from a large multicenter clinical trial (PPCOS).
  
  
  METHODS
  Double-blind, randomized trial of three treatment regimens (with extended release metformin or clomiphene citrate).
  
  
  METHODS
  Academic medical centers.
  
  
  METHODS
  Six hundred twenty-six infertile women with PCOS, aged 18-39 years, with elevated T levels and oligomenorrhea (exclusion of secondary causes), seeking pregnancy, with > or = 1 patent fallopian tube, normal uterine cavity, and a partner with sperm concentration > or = 20 x 10(6)/mL in > or = 1 ejaculate.
  
  
  METHODS
  Baseline characterization.
  
  
  METHODS
  Historical, biometric, and biochemical measures of PCOS.
  
  
  RESULTS
  There were no significant differences in baseline variables between treatment groups. The overall mean (+/-SD) age of the subjects was 28.1 +/- 4.0 years, and the mean body mass index was 35.2 kg/m2 (+/-8.7). Polycystic ovaries (PCOs) were present in 90.3% of the subjects, and the mean volume of each ovary was 10 cm3 or more. Of the subjects, 7% had ovaries that were discordant for PCO morphology. At baseline, 18.3% of the subjects had an abnormal fasting glucose level (> 100 mg/dL). Asians tended to have a milder phenotype, and whites and African Americans were similar in these measures.
  
  
  CONCLUSIONS
  The treatment groups were well matched for baseline parameters, and we have added further information to the PCOS phenotype.
authors.affiliation: Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania 17033, USA. RSL1@PSU.EDU
authors.forename: Richard S
authors.initials: RS
authors.lastname: Legro
authors.forename: Evan R
authors.initials: ER
authors.lastname: Myers
authors.forename: Huiman X
authors.initials: HX
authors.lastname: Barnhart
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Carson
authors.forename: Michael P
authors.initials: MP
authors.lastname: Diamond
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Carr
authors.forename: William D
authors.initials: WD
authors.lastname: Schlaff
authors.forename: Christos
authors.initials: C
authors.lastname: Coutifaris
authors.forename: Peter G
authors.initials: PG
authors.lastname: McGovern
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Cataldo
authors.forename: Michael P
authors.initials: MP
authors.lastname: Steinkampf
authors.forename: John E
authors.initials: JE
authors.lastname: Nestler
authors.forename: Gabriella
authors.initials: G
authors.lastname: Gosman
authors.forename: Linda C
authors.initials: LC
authors.lastname: Guidice
authors.forename: Phyllis C
authors.initials: PC
authors.lastname: Leppert
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D002996:Clomiphene / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007247:Infertility, Female / Q000188:drug therapy* / Q000453:epidemiology*; D008687:Metformin / Q000008:administration & dosage*; D011085:Polycystic Ovary Syndrome / Q000188:drug therapy* / Q000453:epidemiology*; D044469:Racial Groups / Q000706:statistics & numerical data*; D014481:United States / Q000453:epidemiology
chemical_list: D004338:Drug Combinations; D005300:Fertility Agents, Female; D007004:Hypoglycemic Agents; D002996:Clomiphene; D008687:Metformin