COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK

生殖医学合作网络旨在开展 男性和女性领域的大型多中心临床试验 不孕症和生殖疾病及失调。通过测试 假设在普通方案中招募了大量患者， 答案将比单个中心更快地提供， 一个人 这六个临床中心或“生殖医学单位”是 费城宾夕法尼亚大学，马吉妇女医院， 匹兹堡，休斯顿贝勒医学院， 位于戴维斯的加州（在旧金山的Kaiser Permanente有一个“卫星”站点 弗朗西斯科）、布里格姆妇女医院、马萨诸塞州波士顿和大学 在伯明翰的亚拉巴马。数据协调中心（DCC）位于 哥伦比亚大学，纽约市。由于该网络得到了 合作协议，NIH科学工作人员作为一个 担任研究协调员的合作伙伴。 RMU和DCC的主要研究者，NIH研究 协调员和独立主席组成指导委员会。的 指导委员会以协商一致的方式作出决定， 研究、协议设计和执行以及发布。数据安全 由NICHD召集的监督委员会负责 审查临床方案，并提出建议， NICHD是否接受、修改或拒绝拟议的研究。 第一个方案是子宫内与脑内的2x2比较 授精，每次有或没有促性腺激素刺激 卵巢夫妇（n=932）与一个明显正常的女性伴侣，即。 不明原因不孕或男性因素不孕，谁满足 将根据合格性标准进行随机化和入组。促排卵 将在IND下使用Metrodin（人促卵泡素）进行。 预计网络活动最终将包括两个 同步方案，一个用于不孕症，一个用于妇科。

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.