DATA COORDINATING CENTER REPRODUCTIVE MEDICINE NETWORK

合作生殖医学网络旨在开展 男性和女性领域的大型多中心临床试验 不孕不育和生殖疾病及失调。通过测试 在大量按共同方案登记的患者中的假设， 答案将比单个中心采取行动更快地提供 独自一人。 六个临床站点或“生殖医学单位”(RMU)是 宾夕法尼亚大学费城分校，马吉女子医院 匹兹堡大学休斯敦贝勒医学院 加州的戴维斯(在旧金山的Kaiser Permanente有一个“卫星”站点 旧金山)、布里格姆妇女医院、波士顿马萨诸塞州和该大学 在伯明翰的阿拉巴马州。数据协调中心(DCC)位于 哥伦比亚大学，纽约市。由于该网络由 合作协议，NIH科学工作人员的职能是 合作伙伴扮演研究协调员的角色。 美国国立卫生研究院RMU和DCC的首席研究员 协调员和一名独立主席组成了指导委员会。这个 指导委员会以协商一致的方式就以下议题作出决定 研究，协议设计和执行，以及发布。A数据安全 由NICHD召集的监测委员会负责 审查临床方案，并就 NICHD是否接受、修改或拒绝建议的研究。 第一个方案是宫内和宫颈内的2x2比较。 人工授精，每次有或不有促性腺激素的刺激 卵巢。夫妇(n=932)有一个明显正常的女性伴侣，即 不明原因不育症或男性因素不育症，符合 资格标准将是随机的并被录取。促排卵 将在IND下使用Metrodin(人的Follitrop)进行。它 预计网络活动最终将包括两个 同时诊断，一种是不孕症，一种是妇科。

The cooperative Reproductive Medicine Network is designed to carry out large, multicenter clinical trials in the areas of male and female infertility and reproductive diseases and disorders. By testing hypotheses in large numbers of patients enrolled in common protocols, answers will be provided more rapidly than by individual centers acting alone. The six clinical sites or "Reproductive Medicine Units" (RMUs) are The University of Pennsylvania in Philadelphia, Magee-Women's Hospital in Pittsburgh, Baylor College of Medicine in Houston, the University of California at Davis (with a "satellite" site at Kaiser Permanente in San Francisco), Brigham and Women's Hospital, Boston MA, and the University of Alabama at Birmingham. The Data Coordinating Center (DCC) is at Columbia University, New York City. Since the Network is supported by Cooperative Agreements, and NIH scientific staff member functions as a partner in the role of Research Coordinator. The Principal Investigators of the RMU's and DCC, the NIH Research Coordinator, and an independent Chair form the Steering Committee. The Steering Committee makes decisions by consensus, regarding topics to be studied, protocol design and execution, and publication. A Data Safety and Monitoring Committee convened by the NICHD has responsibility for reviewing clinical protocols, and for making a recommendation of the NICHD whether to accept, modify, or decline proposed studies. The first protocol is a 2x2 comparison of intrauterine vs intracervical insemination, each with or without gonadotropin stimulation of the ovaries. Couples (n=932) with an apparently normal female partner, i.e. unexplained infertility or male factor infertility, who meet the eligibility criteria will be randomized and enrolled. Ovulation induction will be carried out using Metrodin (human follitropin) under an IND. It is anticipated that Network activity will eventually encompass two simultaneous protocols, one in infertility and one in gynecology.