Cooperative Multicenter Reproductive Medicine Network UNC Clinical Site

Project: Research project

Description

Abstract

The University of North Carolina at Chapel Hill (UNC) Division of Reproductive Endocrinology (REI) in cooperation with the Center for Women’s Health Research (CWHR) is pleased to submit this proposal to become a member of the Reproductive Medicine Network (RMN). Anne Z. Steiner, MD, MPH is the Principal Investigator of the proposed UNC RMN site. UNC offers a unique academic setting with a history of successful interdepartmental patient care coordination and innovative inter- and transdisciplinary research. The Department of Obstetrics and Gynecology has an active research program with 31 ongoing research projects that includes 3 RO1s, 3 U-type awards, multiple contracts and subcontracts, including 18 clinical trials. The UNC RMN investigators conduct ongoing research in multiple areas of reproductive medicine. Our research portfolio includes clinical trials as well as translational, clinical, and epidemiological research. We have a strong tradition of working collaboratively in our research endeavors, reaching across divisions, departments, and schools within UNC and to universities outside UNC.
The UNC REI Division provides excellent clinical care in reproductive endocrinology and infertility. Their clinical practice, UNC Fertility, offers a continuum of care from in-depth evaluation to comprehensive treatment of patients experiencing problems of infertility, gynecological disorders and diseases, diseases and disorders of the male reproductive system, and endocrinological disorders affecting reproduction. Our patient mix is racially and ethnically diverse. The UNC Fertility clinic is located in the heart of the patient population from which we will recruit, and we have strong track record in recruitment, enrollment, and retention of study participants.

We have assembled a Senior Advisory Team whose members have mastered the intricacies of capitated research funding and have demonstrated 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, who are available to run RMN protocols. Financial support will be provided by the Center for Women’s Health Research, an organization that currently provides fiscal oversight for several other network studies.

Our concept proposal is a randomized controlled trial that examines whether antioxidant therapy improves male fertility. We hypothesize that male antioxidant therapy will improve sperm motility and reduce DNA fragmentation leading to higher fertilization and lower miscarriage rates, resulting in an increase in live births in couples trying to conceive naturally. This proposal addresses the goals of the RMN by facilitating therapeutic solutions to problems in reproductive medicine and focusing on two areas of high programmatic interest to the NICHD: 1) evaluation of therapies to improve sperm quality and natural conception, and 2) evaluation of nutritional supplementation on male fertility.
StatusFinished
Effective start/end date9/24/136/30/18

Funding

  • NIH National Institute of Child Health and Human Development (NICHD)

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Reproductive Medicine
Research
Fertility
Endocrinology
Clinical Trials
Women's Health
Infertility
Randomized Controlled Trials
Antioxidants
National Institute of Child Health and Human Development (U.S.)
Research Personnel
Therapeutics
Financial Support
Hospital Obstetrics and Gynecology Department
Continuity of Patient Care
Time and Motion Studies
Sperm Motility
Live Birth
Spontaneous Abortion
DNA Fragmentation