The Pregnancy in Polycystic Ovary Syndrome Study

baseline characteristics of the randomized cohort including racial effects

Richard S. Legro, Evan R. Myers, Huiman X. Barnhart, Sandra A. Carson, Michael Peter Diamond, Bruce R. Carr, William D. Schlaff, Christos Coutifaris, Peter G. McGovern, Nicholas A. Cataldo, Michael P. Steinkampf, John E. Nestler, Gabriella Gosman, Linda C. Guidice, Phyllis C. Leppert

Research output: Contribution to journalArticle

79 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)914-933
Number of pages20
JournalFertility and sterility
Volume86
Issue number4
DOIs
StatePublished - Oct 1 2006

Fingerprint

Polycystic Ovary Syndrome
Ovary
Pregnancy
Phenotype
Oligomenorrhea
Clomiphene
Fallopian Tubes
Metformin
African Americans
Multicenter Studies
Spermatozoa
Fasting
Body Mass Index
Therapeutics
Outcome Assessment (Health Care)
Clinical Trials
Glucose

Keywords

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

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

The Pregnancy in Polycystic Ovary Syndrome Study : baseline characteristics of the randomized cohort including racial effects. / Legro, Richard S.; Myers, Evan R.; Barnhart, Huiman X.; Carson, Sandra A.; Diamond, Michael Peter; Carr, Bruce R.; Schlaff, William D.; Coutifaris, Christos; McGovern, Peter G.; Cataldo, Nicholas A.; Steinkampf, Michael P.; Nestler, John E.; Gosman, Gabriella; Guidice, Linda C.; Leppert, Phyllis C.

In: Fertility and sterility, Vol. 86, No. 4, 01.10.2006, p. 914-933.

Research output: Contribution to journalArticle

Legro, RS, Myers, ER, Barnhart, HX, Carson, SA, Diamond, MP, Carr, BR, Schlaff, WD, Coutifaris, C, McGovern, PG, Cataldo, NA, Steinkampf, MP, Nestler, JE, Gosman, G, Guidice, LC & Leppert, PC 2006, 'The Pregnancy in Polycystic Ovary Syndrome Study: baseline characteristics of the randomized cohort including racial effects', Fertility and sterility, vol. 86, no. 4, pp. 914-933. https://doi.org/10.1016/j.fertnstert.2006.03.037
Legro, Richard S. ; Myers, Evan R. ; Barnhart, Huiman X. ; Carson, Sandra A. ; Diamond, Michael Peter ; Carr, Bruce R. ; Schlaff, William D. ; Coutifaris, Christos ; McGovern, Peter G. ; Cataldo, Nicholas A. ; Steinkampf, Michael P. ; Nestler, John E. ; Gosman, Gabriella ; Guidice, Linda C. ; Leppert, Phyllis C. / The Pregnancy in Polycystic Ovary Syndrome Study : baseline characteristics of the randomized cohort including racial effects. In: Fertility and sterility. 2006 ; Vol. 86, No. 4. pp. 914-933.
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abstract = "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.",
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AU - Carson, Sandra A.

AU - Diamond, Michael Peter

AU - Carr, Bruce R.

AU - Schlaff, William D.

AU - Coutifaris, Christos

AU - McGovern, Peter G.

AU - Cataldo, Nicholas A.

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