DATA COORDINATING CENTER REPRODUCTIVE MEDICINE NETWORK

数据协调中心生殖医学网络

• 批准号: 2889002
• 负责人: ROBERT E CANFIELD
• 金额: $ 42.4万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-04-01 至 2000-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2889002
• 关键词: clinical trials; computer data analysis; human subject; information systems; mathematics; reproductive system disorder; sex hormones; statistics /biometry

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.

合作生殖医学网络旨在执行 男性和女性领域的大型多中心临床试验 不育和生殖疾病和疾病。通过测试 大量参与共同方案的患者中的假设， 与单个中心行动相比，答案的速度更快 独自的。 六个临床部位或“生殖医学单位”（RMU）是 费城宾夕法尼亚大学，马吉·沃蒙医院的医院 匹兹堡，休斯敦贝勒医学院，大学 加利福尼亚在戴维斯（在圣湾的Kaiser Permanente设有“卫星”地点 Francisco），Brigham and妇女医院，马萨诸塞州波士顿和大学 伯明翰的阿拉巴马州。数据协调中心（DCC）在 纽约市哥伦比亚大学。由于网络由 合作协议，NIH科学人员作为一个 研究协调员角色的合作伙伴。 RMU和DCC的主要研究人员，NIH研究 协调员和指导委员会的独立主席。这 指导委员会通过共识做出决定，关于主题 研究，协议设计和执行以及出版物。数据安全 NICHD召集的监测委员会负责 审查临床方案，并建议 NICHD是接受，修改还是拒绝拟议的研究。 第一个方案是宫内与内部的2x2比较 授精，每种都有或没有促性腺激素的刺激 卵巢。夫妻（n = 932）与女性伴侣明显正常，即 无法解释的不育或男性不育症，他们满足 资格标准将被随机和招募。排卵诱导 将在IND下使用Metrodin（人卵泡素）进行。它 预计网络活动最终将包含两个 同时协议，一个在不育中，一个在妇科中。