Cooperative Multicenter Reproductive Medicine Network UNC Clinical Site

描述(由申请人提供)：北卡罗来纳大学(UNC)REI分部很高兴提交成为生殖医学网络(RMN)成员的建议。北卡罗来纳大学拥有成功的跨部门患者护理协调和创新的跨学科和跨学科研究的历史。妇产科有31个正在进行的研究项目，其中包括3个R01，3个U型奖励，以及多个合同和分包合同，包括18个临床试验。北卡罗来纳大学RMN研究人员在生殖医学的多个领域进行研究，其中包括临床试验、翻译、临床和流行病学研究。在我们的研究工作中，我们有很强的合作传统，在招募和保留研究对象方面，我们有着坚实的记录。该部门的临床实践，北卡罗来纳州生育，提供持续的护理从 深入评估对患有不孕症和其他影响生殖的疾病/障碍患者的综合治疗。我们的患者群体在种族和民族上是多样化的。我们已经组建了一个高级顾问团队，他们的成员已经掌握了复杂的首肯研究资金，并在随机临床试验设计和实施方面拥有专业知识。这些人员将提供指导和投入，将网站作为大型国家网络的一部分进行运营，在北卡罗来纳大学网站可能选择提出的临床试验设计中提供智力支持，并根据需要协助网络协议的实施。目前的分区研究支助团队包括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，旨在测试一项假设，即男性抗氧化剂治疗将改善精子活力，减少DNA碎片，从而在试图自然受孕的夫妇中实现更高的受精率和更低的流产率。这项建议通过集中于NICHD高度关注的两个领域来实现RMN的目标：1)评估改善精子质量和自然受孕的治疗方法；2)评估营养补充对男性生育能力的影响。

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.