Aaron K Styer1, Susan Jin2, Dan Liu2, Baisong Wang3, Alex J Polotsky4, Mindy S Christianson5, Wendy Vitek6, Lawrence Engmann7, Karl Hansen8, Robert Wild8, Richard S Legro9, Christos Coutifaris10, Ruben Alvero11, Randal D Robinson12, Peter Casson13, Gregory M Christman14, Alicia Christy15, Michael P Diamond16, Esther Eisenberg17, Heping Zhang2, Nanette Santoro4. 1. Department of Obstetrics, Gynecology, and Reproductive Biology, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts. Electronic address: astyer@mgh.harvard.edu. 2. Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut. 3. Shanghai, Jiao Tong University, Shanghai, People's Republic of China. 4. Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, Colorado. 5. Department of Obstetrics and Gynecology, Johns Hopkins School of Medicine, Baltimore, Maryland. 6. Department of Obstetrics and Gynecology, University of Rochester School of Medicine, Rochester, New York. 7. Department of Obstetrics and Gynecology, University of Connecticut Health Center, Farmington, Connecticut. 8. Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma. 9. Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania. 10. Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania. 11. Department of Obstetrics and Gynecology, Women and Infants Hospital, Warren Alpert Medical School of Brown University, Providence, Rhode Island. 12. Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, San Antonio, Texas. 13. Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont. 14. Department of Obstetrics and Gynecology, Shands Hospital, University of Florida, Gainesville, Florida. 15. Division of Women's Reproductive Health, US Department of Veteran's Affairs, Washington, DC. 16. Department of Obstetrics and Gynecology, Augusta University, Augusta, Georgia. 17. The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Rockville, Maryland.
Abstract
OBJECTIVE: To investigate the association of non-cavity-distorting uterine fibroids and pregnancy outcomes after ovarian stimulation-intrauterine insemination (OS-IUI) in couples with unexplained infertility. DESIGN: Secondary analysis from a prospective, randomized, multicenter clinical trial investigating fertility outcomes after OS-IUI. SETTING: Reproductive Medicine Network clinical sites. PATIENT(S): Nine hundred couples with unexplained infertility who participated in the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial. INTERVENTION(S): Participants were randomized to one of three arms (clomiphene citrate, letrozole, or gonadotropins), and treatment was continued for up to four cycles or until pregnancy was achieved. MAIN OUTCOMES MEASURE(S): Conception (serum hCG increase), clinical pregnancy (fetal cardiac activity), and live birth rates. RESULT(S): A total of 102/900 participants (11.3%) had at least one documented fibroid and a normal uterine cavity. Women with fibroids were older, more likely to be African American, had a greater uterine volume, lower serum antimüllerian hormone levels, and fewer antral follicles than women without fibroids. In conception cycles, clinical pregnancy rates were significantly lower in participants with fibroids than in those without uterine fibroids. Pregnancy loss before 12 weeks was more likely in African American women with fibroids compared with non-African American women with fibroids. There was no difference in conception and live birth rates in subjects with and without fibroids. CONCLUSION(S): No differences were observed in conception and live birth rates in women with non-cavity-distorting fibroids and those without fibroids. These findings provide reassurance that pregnancy success is not impacted in couples with non-cavity-distorting fibroids undergoing OS-IUI for unexplained infertility. CLINICAL TRIAL REGISTRATION NUMBER: NCT01044862.
RCT Entities:
OBJECTIVE: To investigate the association of non-cavity-distorting uterine fibroids and pregnancy outcomes after ovarian stimulation-intrauterine insemination (OS-IUI) in couples with unexplained infertility. DESIGN: Secondary analysis from a prospective, randomized, multicenter clinical trial investigating fertility outcomes after OS-IUI. SETTING: Reproductive Medicine Network clinical sites. PATIENT(S): Nine hundred couples with unexplained infertility who participated in the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial. INTERVENTION(S): Participants were randomized to one of three arms (clomiphene citrate, letrozole, or gonadotropins), and treatment was continued for up to four cycles or until pregnancy was achieved. MAIN OUTCOMES MEASURE(S): Conception (serum hCG increase), clinical pregnancy (fetal cardiac activity), and live birth rates. RESULT(S): A total of 102/900 participants (11.3%) had at least one documented fibroid and a normal uterine cavity. Women with fibroids were older, more likely to be African American, had a greater uterine volume, lower serum antimüllerian hormone levels, and fewer antral follicles than women without fibroids. In conception cycles, clinical pregnancy rates were significantly lower in participants with fibroids than in those without uterine fibroids. Pregnancy loss before 12 weeks was more likely in African American women with fibroids compared with non-African American women with fibroids. There was no difference in conception and live birth rates in subjects with and without fibroids. CONCLUSION(S): No differences were observed in conception and live birth rates in women with non-cavity-distorting fibroids and those without fibroids. These findings provide reassurance that pregnancy success is not impacted in couples with non-cavity-distorting fibroids undergoing OS-IUI for unexplained infertility. CLINICAL TRIAL REGISTRATION NUMBER: NCT01044862.
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