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 ROIs, 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 and 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 the 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.

Public Health Relevance

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 #
1U10HD077844-01
Application #
8588615
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
$315,608
Indirect Cost
$107,971
Name
University of North Carolina Chapel Hill
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599