The Pregnancy in Polycystic Ovary Syndrome Study: baseline characteristics of the randomized cohort including racial effects

Objective: To report the baseline characteristics and racial differences in the polycystic ovary syndrome (PCOS) phenotype from a large multicenter clinical trial (PPCOS). Design: Double-blind, randomized trial of three treatment regimens (with extended release metformin or clomiphene citrate). Setting: Academic medical centers. Patient(s): 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 ≥1 patent fallopian tube, normal uterine cavity, and a partner with sperm concentration ≥20 × 10⁶/mL in ≥1 ejaculate. Intervention(s): Baseline characterization. Main Outcome Measure(s): Historical, biometric, and biochemical measures of PCOS. Result(s): 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. Conclusion(s): The treatment groups were well matched for baseline parameters, and we have added further information to the PCOS phenotype.