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 > or = 1 patent fallopian tube, normal uterine cavity, and a partner with sperm concentration > or = 20 x 10(6)/mL in > or = 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.
RCT Entities:
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 > or = 1 patent fallopian tube, normal uterine cavity, and a partner with sperm concentration > or = 20 x 10(6)/mL in > or = 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.
Authors: Mira Aubuchon; Allen R Kunselman; William D Schlaff; Michael P Diamond; Christos Coutifaris; Sandra A Carson; Michael P Steinkampf; Bruce R Carr; Peter G McGovern; Nicholas A Cataldo; Gabriella G Gosman; John E Nestler; Evan R Myers; Richard S Legro Journal: J Clin Endocrinol Metab Date: 2011-08-10 Impact factor: 5.958
Authors: Gwinnett Ladson; William C Dodson; Stephanie D Sweet; Anthony E Archibong; Allen R Kunselman; Laurence M Demers; Nancy I Williams; Ponjola Coney; Richard S Legro Journal: Fertil Steril Date: 2011-07 Impact factor: 7.329
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Authors: Alex J Polotsky; Amanda A Allshouse; Peter R Casson; Christos Coutifaris; Michael P Diamond; Gregory M Christman; William D Schlaff; Ruben Alvero; J C Trussell; Stephen A Krawetz; Nanette Santoro; Esther Eisenberg; Heping Zhang; Richard S Legro Journal: J Clin Endocrinol Metab Date: 2015-04-09 Impact factor: 5.958
Authors: Mark O Goodarzi; Michelle R Jones; Xiaohui Li; Angela K Chua; Obed A Garcia; Yii-Der I Chen; Ronald M Krauss; Jerome I Rotter; Wendy Ankener; Richard S Legro; Ricardo Azziz; Jerome F Strauss; Andrea Dunaif; Margrit Urbanek Journal: J Med Genet Date: 2011-12-17 Impact factor: 6.318
Authors: Lauren W Roth; Hao Huang; Richard S Legro; Michael P Diamond; Christos Coutifaris; Sandra A Carson; Michael P Steinkampf; Bruce R Carr; Peter G McGovern; Nicholas A Cataldo; Gabriella G Gosman; John E Nestler; Evan R Myers; Heping Zhang; William D Schlaff Journal: Obstet Gynecol Date: 2012-06 Impact factor: 7.661
Authors: Richard S Legro; Huiman X Barnhart; William D Schlaff; Bruce R Carr; Michael P Diamond; Sandra A Carson; Michael P Steinkampf; Christos Coutifaris; Peter G McGovern; Nicholas A Cataldo; Gabriella G Gosman; John E Nestler; Linda C Giudice; Kathryn G Ewens; Richard S Spielman; Phyllis C Leppert; Evan R Myers Journal: J Clin Endocrinol Metab Date: 2007-11-13 Impact factor: 5.958