Erica T Wang1, Michael P Diamond2, Ruben Alvero3, Peter Casson4, Gregory M Christman5, Christos Coutifaris6, Karl R Hansen7, Fangbai Sun8, Richard S Legro9, Randal D Robinson10, Rebecca S Usadi11, Margareta D Pisarska12, Nanette F Santoro3, Heping Zhang8. 1. Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: erica.wang@cshs.org. 2. Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta University, Augusta, Georgia. 3. Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado. 4. Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont. 5. Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville, Florida. 6. Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania. 7. Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma. 8. Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut. 9. Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania. 10. Department of Obstetrics and Gynecology, University of Texas Health San Antonio Long School of Medicine, San Antonio, Texas. 11. Department of Obstetrics and Gynecology, Atrium Health, Charlotte, North Carolina. 12. Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California.
Abstract
OBJECTIVE: To determine whether biochemical or clinical markers of androgenic activity predict live birth rate with ovarian stimulation in the unexplained infertility population. DESIGN: Secondary analysis of the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial. SETTING: Multicenter university-based clinical practices. PATIENT(S): Nine hundred couples with unexplained infertility were included. Women were 18-40 years old with regular menses, a normal uterine cavity, at least one patent fallopian tube, and a male partner with ≥5 million motile sperm. Women were randomized to receive gonadotropin, clomiphene, or letrozole with IUI for four or fewer four treatment cycles. Women were evaluated for biochemical (total testosterone, DHEAS, and free androgen index) and clinical markers of androgenic activity (sebum, acne, and hirsutism). Multivariable logistic regression models adjusting for treatment group, maternal age, and body mass index were performed. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The primary outcome was live birth. Secondary outcomes included conception, clinical pregnancy, and pregnancy loss. RESULT(S): When comparing 900 women in the AMIGOS trial based on quartiles of serum TT, women were of younger age, higher body mass index, and higher waist circumference with increasing TT. Increasing quartiles of TT also showed increasing DHEAS and free androgen index values. Serum androgens were not associated with outcomes of live birth, conception, clinical pregnancy, or pregnancy loss. Clinical androgen markers were not associated with pregnancy outcomes. CONCLUSION(S): In a randomized cohort of women with unexplained infertility, biochemical and clinical measures of androgens did not predict live birth rate after ovarian stimulation treatment. CLINICAL TRIAL REGISTRATION NUMBER: NCT 01044862.
RCT Entities:
OBJECTIVE: To determine whether biochemical or clinical markers of androgenic activity predict live birth rate with ovarian stimulation in the unexplained infertility population. DESIGN: Secondary analysis of the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial. SETTING: Multicenter university-based clinical practices. PATIENT(S): Nine hundred couples with unexplained infertility were included. Women were 18-40 years old with regular menses, a normal uterine cavity, at least one patent fallopian tube, and a male partner with ≥5 million motile sperm. Women were randomized to receive gonadotropin, clomiphene, or letrozole with IUI for four or fewer four treatment cycles. Women were evaluated for biochemical (total testosterone, DHEAS, and free androgen index) and clinical markers of androgenic activity (sebum, acne, and hirsutism). Multivariable logistic regression models adjusting for treatment group, maternal age, and body mass index were performed. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The primary outcome was live birth. Secondary outcomes included conception, clinical pregnancy, and pregnancy loss. RESULT(S): When comparing 900 women in the AMIGOS trial based on quartiles of serum TT, women were of younger age, higher body mass index, and higher waist circumference with increasing TT. Increasing quartiles of TT also showed increasing DHEAS and free androgen index values. Serum androgens were not associated with outcomes of live birth, conception, clinical pregnancy, or pregnancy loss. Clinical androgen markers were not associated with pregnancy outcomes. CONCLUSION(S): In a randomized cohort of women with unexplained infertility, biochemical and clinical measures of androgens did not predict live birth rate after ovarian stimulation treatment. CLINICAL TRIAL REGISTRATION NUMBER: NCT 01044862.
Authors: Michael P Diamond; Richard S Legro; Christos Coutifaris; Ruben Alvero; Randal D Robinson; Peter Casson; Gregory M Christman; Joel Ager; Hao Huang; Karl R Hansen; Valerie Baker; Rebecca Usadi; Aimee Seungdamrong; G Wright Bates; R Mitchell Rosen; Daniel Haisenleder; Stephen A Krawetz; Kurt Barnhart; J C Trussell; Dana Ohl; Yufeng Jin; Nanette Santoro; Esther Eisenberg; Heping Zhang Journal: N Engl J Med Date: 2015-09-24 Impact factor: 91.245
Authors: Michael P Diamond; Richard S Legro; Christos Coutifaris; Ruben Alvero; Randal D Robinson; Peter Casson; Gregory M Christman; Joel Ager; Hao Huang; Karl R Hansen; Valerie Baker; Rebecca Usadi; Aimee Seungdamrong; G Wright Bates; R Mitchell Rosen; Daniel Haisonleder; Stephen A Krawetz; Kurt Barnhart; J C Trussell; Yufeng Jin; Nanette Santoro; Esther Eisenberg; Heping Zhang Journal: Fertil Steril Date: 2015-02-20 Impact factor: 7.329
Authors: Robert L Barbieri; Pat M Sluss; Robert D Powers; Patricia M McShane; Allison Vitonis; Elizabeth Ginsburg; Daniel C Cramer Journal: Fertil Steril Date: 2005-02 Impact factor: 7.329
Authors: Richard S Legro; William D Schlaff; Michael P Diamond; Christos Coutifaris; Peter R Casson; Robert G Brzyski; Gregory M Christman; J C Trussell; Stephen A Krawetz; Peter J Snyder; Dana Ohl; Sandra A Carson; Michael P Steinkampf; Bruce R Carr; Peter G McGovern; Nicholas A Cataldo; Gabriella G Gosman; John E Nestler; Evan R Myers; Nanette Santoro; Esther Eisenberg; Meizhuo Zhang; Heping Zhang Journal: J Clin Endocrinol Metab Date: 2010-09-08 Impact factor: 5.958
Authors: J K Bosdou; C A Venetis; K Dafopoulos; L Zepiridis; K Chatzimeletiou; G Anifandis; A Mitsoli; A Makedos; I E Messinis; B C Tarlatzis; E M Kolibianakis Journal: Hum Reprod Date: 2016-03-07 Impact factor: 6.918