The University of Oklahoma Section of Reproductive Endocrinology and Infertility is uniquely positioned to provide a geographically distinct and ethnically diverse study site forthe Reproductive Medicine Network. The OU-RMNU brings a cadre of clinician scientists and physicians to the RMN as well as a research nurse, a regulatory specialist and a database manager. This experienced team has been involved in clinical trials and investigations involving unexplained infertility, polycystic ovarian syndrome, and reproductive aging in women. In addition, our strengths include our large clinical volume and the wide variety of reproductive disorders treated in our clinic. Our concept proposal titled "Luteal Progesterone Supplementation in Clomiphene Citrate-lntrauterine Insemination (CC-IUI) Treatment Cycles for Unexplained Infertility" provides a demonstration of the collaborative nature of our section and our research interests. Recent observational and small prospective studies have suggested that luteal phase progesterone supplementation may improve live-birth rates in women with unexplained infertility undergoing superovulation-IUI treatments. However, all of these investigations have methodological weaknesses and are underpowered. Given the low cost and high utilization of these treatments as compared to the cost of IVF, even small improvements in live-birth rates would be clinically meaningful. The primary goal of this investigation is to determine whether progesterone supplementation in the luteal phase improves the live-birth rate in couples undergoing treatment with CC-IUI for unexplained infertility. Secondary aims include evaluating differences in clinical pregnancy and spontaneous abortion rates in women treated with progesterone supplementation compared to women in the placebo control. This investigation will address the above questions with an appropriately powered multicenter, placebo-controlled, double-blinded clinical trial that will enroll 720 couples with unexplained infertility. The identification of effective evidence-based treatments for couples with unexplained infertility is vitally important given the burden of infertility on society, and is directly responsive to the NICHD's mission.

Public Health Relevance

Identifying effective treatements with low multiple pregnancy rates for couples with unexplained infertility is vitally important given the burden of infertility on society. The proposed investigation will determine whether supplemental progesterone improves pregnancy rates in women with unexplained infertility that undergo commonly utilized fertility treatments.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10HD077680-01
Application #
8585992
Study Section
Special Emphasis Panel (ZHD1-DSR-L (55))
Program Officer
De Paolo, Louis V
Project Start
2013-09-24
Project End
2018-06-30
Budget Start
2013-09-24
Budget End
2014-06-30
Support Year
1
Fiscal Year
2013
Total Cost
$221,574
Indirect Cost
$71,862
Name
University of Oklahoma Health Sciences Center
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
878648294
City
Oklahoma City
State
OK
Country
United States
Zip Code
73117