GHSU/WSU Cooperative Reproductive Medicine Network

GHSU/WSU 合作生殖医学网络

• 批准号: 8588686
• 负责人: Michael Peter Diamond
• 金额: $ 31.41万
• 依托单位: AUGUSTA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-06-30 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8588686
• 关键词: Academy; Address; Advisory Committees; American; Arteries; Attention; Award; Biological Markers; Biopsy; Birth; Birth Rate; Categories; Characteristics; Child; Clinical Investigator; Clinical Research; Clinical Trials; Clomiphene Citrate; Commit; Communities; Complex; Conceptions; Conduct Clinical Trials; Coupled; Data; Data Analyses; Development; Diagnostic; Diamond; Disease; Documentation; Endometrial; Endometrium; Enrollment; Evaluation; Fertility; Fostering; Future; Genomics; Goals; Health Sciences; Hemorrhage; Hormonal; Hormones; Human; Individual; Institute of Medicine (U.S.); Institution; Joints; Live Birth; Luteal Phase; Medical center; Medicine; Mentors; Mentorship; Minority; Morphology; National Institute of Child Health and Human Development; Oral; Outcome; Ovarian Stimulations; Ovulation; Patients; Persons; Pharmaceutical Preparations; Placentation; Polycystic Ovary Syndrome; Practice Guidelines; Pregnancy; Pregnancy Outcome; Principal Investigator; Progestins; Proteomics; Protocol Compliance; Protocols documentation; Randomized; Recording of previous events; Recovery; Reporting; Reproductive Health; Reproductive Medicine; Research; Research Personnel; Research Project Grants; Resources; Rural Population; Science; Serum; Site; Solutions; Source; Specific qualifier value; Specimen; System; Testing; Therapeutic; Time; Training; Ultrasonography; United States National Institutes of Health; Universities; Urban Population; Velocimetries; Withdrawal; Woman; Work; Writing; base; biobank; clinical care; clinical practice; cohort; comparative effectiveness; design; expectation; experience; improved; innovation; meetings; member; men; novel; patient population; programs; proliferative phase Menstrual cycle; public health relevance; reproductive; stem; volunteer

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.

描述（由申请人提供）：这项合作佐治亚州健康科学大学/韦恩州立大学更新提交的总体目标是改善男性和女性的生殖健康，从而促进健康，需要的孩子的诞生。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。其中包括对合作临床研究的承诺和记录 - 例如，在过去五年中，由RMN转向和咨询委员会批准的三个方案以及主题入学率的出色记录。这两个机构共同提供了一个特别庞大的患者基础（包括少数族裔的极高比例），从而将受试者纳入了新的和正在进行的网络协议中。拟议的支持期的概念方案源于多囊卵巢综合征研究中对RMN怀孕的数据的最新分析，其中申请人确定了一种新的结果：在服用生育能力降低的概念和活产生的妇女之前，诱导孕激素的孕激素流血的标准临床实践是诱导生育能力的脱脂剂。鉴于这种清晰的观察，一项创新的研究旨在利用它。中心假设是，孕激素诱导戒断出血将对WHO WHO患有先前发作周期的II类女性的现场出生结果有害。为了检验这一假设，我们将追求三个具体的目标：1）确定接受柠檬酸克罗米芬（CC）的妇女的活产率，或者在戒断之前有或没有孕激素； 2）同时确定此类妇女怀孕时间； 3）确定孕激素戒断对黄体期荷尔蒙环境和子宫内膜的影响。预期的结果是，我们在网络中的会员资格的续签将允许对集团的合作项目以及该集团考虑的新研究项目的创新进行持续贡献。再加上我们的农村和城市人口的扩大，在RMN试验中成为种族多元化患者的主要招聘者的文献，恒星的协议依从性，较强的口头和书面历史和书面的RMN成果的传播以及个性化的关注以及对指导者身份的关注以及对初级临床研究者的培训以及这些临床研究的范围，并将其验证和探索能力确定或识别其范围或识别其目标，以确定其目标或识别其目标，以识别其实现的目标，以识别其实现的目标，以实现其目标，以识别其实现的目标。生殖医学问题。