Cooperative Multicenter Reproductive Medicine Network

多中心生殖医学合作网络

• 批准号: 7293123
• 负责人: Michael Peter Diamond
• 金额: $ 30.1万
• 依托单位: WAYNE STATE 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 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7293123
• 关键词: Address; Aromatase Inhibitors; Birth; Caring; Child; Child Mortality; Clinical Research; Commit; Couples; Data Quality; Economic Burden; Enrollment; Environment; Extramural Activities; Fostering; Funding; Goals; Gonadotropins; Human Resources; Infertility; Institute of Medicine (U.S.); Life; Minority; Morbidity - disease rate; Numbers; Outcome; Ovarian Stimulations; Ovary; Ovulation; Patients; Perinatology; Population; Pregnancy; Pregnancy Rate; Protocols documentation; Public Health; Rate; Recommendation; Recording of previous events; Reproductive Health; Reproductive Medicine; Research; Research Activity; Resources; Societies; United States National Institutes of Health; Universities; Urban Population; Wages; Woman; base; clinically significant; concept; design; experience; improved; intrauterine insemination; male health; member; novel; reproductive

DESCRIPTION (provided by applicant): Our overall goal is to improve reproductive health of men and women, thereby fostering the birth of healthy, wanted children. The objective of this renewal application is to remain part of the Cooperative Multi-center Reproductive Medicine Network (RMN). We are committed to cooperative research and offer a large patient base (including a large minority population) from which to enroll subjects into Network protocols. We propose to achieve this objective by documenting that Wayne State University's (WSU) spectrum of research experience, expertise, and resources are consistent with successful participation in the RMN, by providing evidence of WSU's commitment and track record in cooperative clinical research (specifically our history of high RMN subject enrollment and data quality over the past seven years), and by providing a 'concept' protocol as proof of our ability to conceive and design a cooperative project. Institutional and departmental support for the RMN is strong, fostering an environment supportive of, and conducive for, collaborative clinical research (including extensive extramural funding, and the presence of the NIH Intramural Perinatology Research Branch) and with substantive support (e.g., funding for salaries, research activities, and $17 million renovation of the department's 75,000 sq. ft. C.S. Mott Center that is dedicated to women's reproductive health). WSU RMN key personnel each have over ten year's experience in reproductive research at WSU, with a long track record of NIH funding, design and conduct of multi-center trials, and regulatory review experience. We expect to be an integral, contributing member of the RMN in research identified by others, and an innovator of novel, clinically significant projects. We would contribute to meeting major identified needs in our field, as exemplified by our concept protocol, which addresses the Institute of Medicine's recommendation to reduce the rate of multiple gestation pregnancies. The specific objective of our concept protocol is to identify a pharmacologic agent that will reliably produce ovulation, but not super ovulation. The central hypothesis is that in infertile women undergoing ovarian stimulation and intrauterine insemination, the use of aromatase inhibitors will stimulate the ovaries sufficiently to produce no reduction in the rate of pregnancy, while significantly reducing the number of multiple gestational pregnancies that result from stimulation with gonadotropins. The RMN is vital to successful completion of this protocol to assure timely recruitment of the number of subjects needed to reach the sufficient power required to interpret results accurately. Relevance to Public Health: Re-funding of the WSU RMN would provide access to, and allow care for, the urban population we serve. Successful outcomes of our concept proposal would be significant because a positive result would allow reduction of the life-long morbidity and mortality of children from multiple gestational pregnancies, thereby decreasing the economic burden to these couples and society.

描述（由申请人提供）：我们的总体目标是改善男性和女性的生殖健康，从而促进健康，想要的孩子的出生。本次更新申请的目的是保持合作多中心生殖医学网络（RMN）的一部分。我们致力于合作研究，并提供大量的患者基础（包括大量的少数民族人口），从中招募受试者进入网络协议。我们建议通过记录韦恩州立大学（WSU）的研究经验、专业知识和资源与成功参与RMN一致，并通过提供WSU在合作临床研究中的承诺和跟踪记录的证据来实现这一目标（特别是我们在过去七年中的高RMN受试者入组和数据质量的历史），并通过提供一个“概念”协议来证明我们有能力构思和设计一个合作项目。对RMN的机构和部门支持是强大的，促进了支持和有利于合作临床研究的环境（包括广泛的校外资金，以及NIH校内围产期研究分支的存在），并提供了实质性的支持（例如，资助薪金，研究活动，以及耗资1700万美元翻新该部门的75，000平方米。英尺C.S.莫特中心致力于妇女的生殖健康）。WSU RMN的主要工作人员都有超过十年的WSU生殖研究经验，具有NIH资助，多中心试验设计和实施以及监管审查经验的长期记录。我们希望成为RMN在其他人确定的研究中不可或缺的贡献成员，以及新颖的临床重要项目的创新者。我们将为满足本领域已确定的主要需求作出贡献，我们的概念议定书就是一个例证，该议定书涉及医学研究所关于降低多胎妊娠率的建议。我们的概念方案的具体目标是确定一种药物，将可靠地产生排卵，但不是超排卵。中心假设是，在接受卵巢刺激和宫腔内人工授精的不孕妇女中，使用芳香酶抑制剂将充分刺激卵巢，不降低妊娠率，同时显著减少促性腺激素刺激导致的多胎妊娠的数量。RMN对于成功完成本方案至关重要，以确保及时招募所需的受试者数量，以达到准确解读结果所需的足够把握度。与公共卫生的相关性：对WSU RMN的重新资助将为我们所服务的城市人口提供服务。我们的概念提案的成功结果将是重要的，因为积极的结果将允许减少多胎妊娠儿童的终身发病率和死亡率，从而减轻这些夫妇和社会的经济负担。