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).


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.
Legro
Richard S
RS
Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania 17033, USA. RSL1@PSU.EDU
Myers
Evan R
ER
Barnhart
Huiman X
HX
Carson
Sandra A
SA
Diamond
Michael P
MP
Carr
Bruce R
BR
Schlaff
William D
WD
Coutifaris
Christos
C
McGovern
Peter G
PG
Cataldo
Nicholas A
NA
Steinkampf
Michael P
MP
Nestler
John E
JE
Gosman
Gabriella
G
Guidice
Linda C
LC
Leppert
Phyllis C
PC
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
D004338:Drug Combinations; D005300:Fertility Agents, Female; D007004:Hypoglycemic Agents; D002996:Clomiphene; D008687:Metformin