GHSU/WSU Cooperative Reproductive Medicine Network

描述（由申请人提供）：佐治亚健康科学大学/韦恩州立大学合作更新提交的总体目标是改善男性和女性的生殖健康，从而促进生育健康、理想的儿童。为了实现这一目标，申请人建议继续为生殖医学网络（RMN）贡献广泛的研究专业知识和资源。这包括对合作临床研究的承诺和记录——例如，在过去五年中，RMN指导和咨询委员会批准了三个方案，以及受试者登记的优秀记录。这两个机构共同提供了一个特别大的患者基础（包括非常高比例的少数民族），从中招募受试者进入新的和正在进行的网络协议。拟议支持期的概念方案源于最近对RMN的多囊卵巢综合征妊娠研究数据的二次分析，在该研究中，申请人确定了一个新的结果：与未接受黄体酮治疗的无排卵妇女相比，在给予生育药物之前诱导黄体酮戒除性出血的标准临床实践显着降低了受孕率和活产率。鉴于这一明确的观察结果，设计了一项创新研究来利用它。中心假设是，使用黄体酮诱导停药出血将对有先前无排卵周期的世卫组织第二类妇女的活产结果产生不利影响。为了验证这一假设，我们将追求三个具体目标：1)确定这些接受枸橼酸克罗米芬（CC）的妇女的活产率，是否预先停药；2)同时确定此类妇女的怀孕时间；3)测定停药对黄体期激素环境及子宫内膜的影响。预期的结果是，我们在该网络中的成员资格的更新将允许我们继续为该集团的合作项目做出贡献，并为该集团考虑的新研究项目创新。再加上我们扩大的农村和城市人口，作为RMN试验中不同种族患者的主要招募者的记录，遵守协议的良好历史，口头和书面传播RMN结果的良好历史，以及对初级临床研究者的个性化指导和培训，预期这些将对该网络实现确定和（或）改进生殖医学问题的诊断和治疗解决办法的目标的能力产生重大的积极影响。

DESCRIPTION (provided by applicant): The overall goal of this collaborative Georgia Health Sciences University/Wayne State University renewal submission is to improve the reproductive health of men and women, thereby fostering the birth of healthy, desired children. To achieve this goal the applicants propose to continue to contribute a broad spectrum of research expertise and resources to the Reproductive Medicine Network (RMN). These include a commitment to and track record in cooperative clinical research - e.g., three protocols approved by the RMN Steering and Advisory Committees over the past five years, as well as a superior record of subject enrollment. The two institutions collectively offer an especially large patient base (including an extraordinarily high percentage of minorities) from which to enroll subjects into new and ongoing Network protocols. The concept protocol for the proposed period of support stems from recent secondary analysis of data from the RMN's Pregnancy in Polycystic Ovary Syndrome study, in which the applicants identified a novel outcome: the standard clinical practice of inducing a progestin-withdrawal bleed prior to administration of fertility medications dramatically decreased conception and live birth rates, compared to anovulatory women not treated with progestins. In view of this clear-cut observation, an innovative study has been designed to capitalize on it. The central hypothesis is that progestin administration to induce a withdrawal bleed will have a detrimental effect on live birth outcome in WHO Category II women with a prior anovulatory cycle. To test this hypothesis, we will pursue three specific aims: 1) Determine the rate of live births among such women receiving clomiphene citrate (CC), with or without preceding progestin withdrawal; 2) Concomitantly determine the time to pregnancy in such women; and 3) Determine the influence of progestin withdrawal on the luteal phase hormonal milieu and the endometrium. The expected outcome is that renewal of our membership in the Network would allow continued contribution to the group's cooperative projects, as well as innovation of new research projects for consideration by the group. Coupled with our enlarged joint rural and urban population, documentation of being a major recruiter of racially diverse patients in RMN trials, stellar history of protocol compliance, strong history of oral and written dissemination of RMN results, and personalized attention to mentorship and training of junior clinical investigators, these are expected to have significant positive impact o the Network's capacity to attain its goal of identifying and/or improving diagnostic and therapeutic solutions to problems in reproductive medicine.