Cooperative Multicenter Reproductive Medicine Network UNC Clinical Site

描述（由申请人提供）：REI的北卡罗来纳州大学分部很高兴提交此提案，成为生殖医学网络（RMN）的成员。在跨部门的病人护理协调和创新的跨学科和跨学科的研究方面有着成功的历史。妇产科有31个正在进行的研究项目，包括3个R 01，3个U型奖项，以及多个合同和分包合同，包括18个临床试验。RMN研究人员在生殖医学的多个领域进行研究，包括临床试验、转化、临床和流行病学研究。我们有一个在我们的研究工作和招聘和研究对象的保留坚实的跟踪记录合作的强大传统。该司的临床实践，生育，提供了一个连续的照顾， 深入评价对患有不孕症和其他影响生殖的疾病/失调的患者的综合治疗。我们的患者群体是种族和民族多样化的。我们已经组建了一个高级顾问团队，其成员掌握了复杂的资本研究资金，并在随机临床试验设计和实施的专业知识。这些人将提供指导和输入操作一个网站作为一个大型的国家网络的一部分，提供智力支持的临床试验的设计，该网站可能会选择提出，并协助实施网络协议的需要。目前的部门研究支持团队包括2名全职研究协调员，1名全职实验室经理，1名全职和2名兼职研究助理。财政监督将由妇女健康研究中心提供。我们的概念提案是一项随机对照试验，旨在验证男性抗氧化剂治疗将提高精子活力并减少DNA片段化的假设，从而提高受精率并降低自然受孕夫妇的流产率。该提案通过关注NICHD高度关注的两个领域来实现RMN的目标：1）评价改善精子质量和自然受孕的疗法，2）评价营养补充剂对男性生育力的影响。

DESCRIPTION (provided by applicant): 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.