Elsevier

Fertility and Sterility

Volume 86, Issue 4, October 2006, Pages 914-933
Fertility and Sterility

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

https://doi.org/10.1016/j.fertnstert.2006.03.037Get rights and content
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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.

Key Words

Randomized controlled trial
insulin resistance
ethnicitye
ethnicity
ultrasound
obesity
metabolic syndrome
infertility
metformin
clomiphene
ovulation induction

Cited by (0)

Supported by National Institutes of Health/National Institute of Child Health and Human Development grants U10 HD27049 (C.C.), U01 HD38997 (E.M.), U10 HD39005 (M.D.), U10 HD27011 (S.C.), U10 HD33172 (M.S.), U10 HD38988 (B.C.), U10 HD38992 (R.L.), U10 HD38998 (W.S.), U10 HD38999 (P.McG.), and U54 HD29834 (University of Virginia Center for Research in Reproduction Ligand Assay and Analysis Core), and General Clinical Research Center grant MO1RR00056 to the University of Pittsburgh and MO1RR10732 and construction grant C06 RR016499 to Pennsylvania State University.