The University of North Carolina (UNC) Division of REI is pleased to submit this proposal to become a member of the Reproductive Medicine Network (RMN). UNC has a history of successful interdepartmental patient care coordination and innovative inter- and transdisciplinary research. The Department of Obstetrics and Gynecology has 31 ongoing research projects that include 3 R01s, 3 U-type awards, and multiple contracts and subcontracts, including 18 clinical trials. UNC RMN investigators conduct research in multiple areas of reproductive medicine in a portfolio that includes clinical trials an translational, clinical, and epidemiological research. We have a strong tradition of working collaboratively in our research endeavors and a solid track record of recruitment and retention of research subjects. The Division's clinical practice, UNC Fertility, offers a continuum of care from in-depth evaluation to comprehensive treatment of patients experiencing problems of infertility and other diseases/disorders affecting reproduction. Our patient population is racially and ethnically diverse. We have assembled a Senior Advisory Team whose members have mastered the intricacies of capitated research funding and have expertise in randomized clinical trial design and implementation. These individuals will be available to provide guidance and input into operating a site as part of a large national network, provide intellectual support in th design of clinical trials that the UNC site may choose to propose, and assist with the implementation of network protocols as needed. The current divisional research support team includes 2 full-time study coordinators, 1 full-time lab manager, and 1 full-time and 2 part-time research assistants. Fiscal oversight will be provided by the Center for Women's Health Research. Our concept proposal is a randomized controlled trial designed to test the hypothesis that male antioxidant therapy will improve sperm motility and reduce DNA fragmentation leading to higher fertilization and lower miscarriage rates in couples trying to conceive naturally. This proposal addresses goals of the RMN by focusing on two areas of high interest to the NICHD: 1) evaluation of therapies to improve sperm quality and natural conception and 2) evaluation of the effect of nutritional supplementation on male fertility.

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 #
5U10HD077844-02
Application #
8740532
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
De Paolo, Louis V
Project Start
2013-09-24
Project End
2018-06-30
Budget Start
2014-07-01
Budget End
2015-06-30
Support Year
2
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Mumford, Sunni L; Legro, Richard S; Diamond, Michael P et al. (2016) Baseline AMH Level Associated With Ovulation Following Ovulation Induction in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab 101:3288-96
Steiner, Anne Z; Diamond, Michael P; Legro, Richard S et al. (2015) Chlamydia trachomatis immunoglobulin G3 seropositivity is a predictor of reproductive outcomes in infertile women with patent fallopian tubes. Fertil Steril 104:1522-6