Abstract
Objective To summarize baseline characteristics from a large multicenter infertility clinical trial. Design Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene). Setting Academic Health Centers throughout the United States. Patient(s) Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study. Intervention(s) None. Main Outcome Measure(s) Historic, biometric, biochemical, and questionnaire parameters. Result(s) Females averaged 30 years and were obese (body mass index [BMI] 35) with ∼20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). Most of the women had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH-to-FSH ratio (∼2), and antimüllerian hormone levels (8.0 ng/mL). In addition, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH-to-FSH levels, antimüllerian hormone levels, and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Men were obese (BMI 30) and had normal mean semen parameters. Conclusion(s) The treatment groups were well matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. Clinical Trial Registration Number NCT00719186.
| Original language | English (US) |
|---|---|
| Journal | Fertility and sterility |
| Volume | 101 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 1 2014 |
Fingerprint
Keywords
- Insulin resistance
- hirsutism
- infertility
- metabolic syndrome
- ovulation induction
ASJC Scopus subject areas
- Reproductive Medicine
- Obstetrics and Gynecology
Cite this
The pregnancy in polycystic ovary syndrome II study : Baseline characteristics and effects of obesity from a multicenter randomized clinical trial. / Legro, Richard S.; Brzyski, Robert G.; Diamond, Michael Peter; Coutifaris, Christos; Schlaff, William D.; Alvero, Ruben; Casson, Peter; Christman, Gregory M.; Huang, Hao; Yan, Qingshang; Haisenleder, Daniel J.; Barnhart, Kurt T.; Bates, G. Wright; Usadi, Rebecca; Lucidi, Richard; Baker, Valerie; Trussell, J. C.; Krawetz, Stephen A.; Snyder, Peter; Ohl, Dana; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping.
In: Fertility and sterility, Vol. 101, No. 1, 01.01.2014.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The pregnancy in polycystic ovary syndrome II study
T2 - Baseline characteristics and effects of obesity from a multicenter randomized clinical trial
AU - Legro, Richard S.
AU - Brzyski, Robert G.
AU - Diamond, Michael Peter
AU - Coutifaris, Christos
AU - Schlaff, William D.
AU - Alvero, Ruben
AU - Casson, Peter
AU - Christman, Gregory M.
AU - Huang, Hao
AU - Yan, Qingshang
AU - Haisenleder, Daniel J.
AU - Barnhart, Kurt T.
AU - Bates, G. Wright
AU - Usadi, Rebecca
AU - Lucidi, Richard
AU - Baker, Valerie
AU - Trussell, J. C.
AU - Krawetz, Stephen A.
AU - Snyder, Peter
AU - Ohl, Dana
AU - Santoro, Nanette
AU - Eisenberg, Esther
AU - Zhang, Heping
PY - 2014/1/1
Y1 - 2014/1/1
N2 - Objective To summarize baseline characteristics from a large multicenter infertility clinical trial. Design Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene). Setting Academic Health Centers throughout the United States. Patient(s) Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study. Intervention(s) None. Main Outcome Measure(s) Historic, biometric, biochemical, and questionnaire parameters. Result(s) Females averaged 30 years and were obese (body mass index [BMI] 35) with ∼20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). Most of the women had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH-to-FSH ratio (∼2), and antimüllerian hormone levels (8.0 ng/mL). In addition, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH-to-FSH levels, antimüllerian hormone levels, and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Men were obese (BMI 30) and had normal mean semen parameters. Conclusion(s) The treatment groups were well matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. Clinical Trial Registration Number NCT00719186.
AB - Objective To summarize baseline characteristics from a large multicenter infertility clinical trial. Design Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene). Setting Academic Health Centers throughout the United States. Patient(s) Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study. Intervention(s) None. Main Outcome Measure(s) Historic, biometric, biochemical, and questionnaire parameters. Result(s) Females averaged 30 years and were obese (body mass index [BMI] 35) with ∼20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). Most of the women had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH-to-FSH ratio (∼2), and antimüllerian hormone levels (8.0 ng/mL). In addition, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH-to-FSH levels, antimüllerian hormone levels, and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Men were obese (BMI 30) and had normal mean semen parameters. Conclusion(s) The treatment groups were well matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. Clinical Trial Registration Number NCT00719186.
KW - Insulin resistance
KW - hirsutism
KW - infertility
KW - metabolic syndrome
KW - ovulation induction
UR - http://www.scopus.com/inward/record.url?scp=84891557755&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84891557755&partnerID=8YFLogxK
U2 - 10.1016/j.fertnstert.2013.08.056
DO - 10.1016/j.fertnstert.2013.08.056
M3 - Article
AN - SCOPUS:84891557755
VL - 101
JO - Fertility and Sterility
JF - Fertility and Sterility
SN - 0015-0282
IS - 1
ER -