COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK

协作多中心生殖医学网络

• 批准号: 6387570
• 负责人: Sandra Carson
• 金额: $ 21.68万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-04-01 至 2005-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6387570
• 关键词: clinical research; clinical trials; cooperative study; diagnosis design /evaluation; ectopic pregnancy; experimental designs; female; fertility; human pregnant subject; human subject; human therapy evaluation; methotrexate; pregnancy disorder chemotherapy; prenatal diagnosis; ultrasonography

Technologic advancements allowing the early, nonsurgical diagnosis of ectopic pregnancy prompted the initiation of medical therapy for ectopic pregnancy. The medical regimens became popularized without efficacy assessment or rigid criteria for the limitations of usage. In May, 1999 the Reproductive Medicine Network initiated a pilot protocol to 1) compare the efficacy of single dose methotrexate and multiple dose methotrexate in the treatment of ectopic pregnancy and 2) determine the limitations of usage for each protocol. The Principal Investigator of this application is the principal author of the prospective randomized trial for this project, a project well suited for the multicenter network because of its importance to public health and its need for a large number of subjects due to the expected small differences in efficacy. As a Reproductive Medicine Network member for 10 years, the Principal Investigator and Co-Investigator have had a major role in the two completed network studies. We contributed 225 subjects or 24 percent of the total, to the project, "Randomized Treatment of Unexplained Infertility", with 32 percent of the resultant pregnancies.' A comparable number were recruited for the "Evaluation of Semen Parameters in Fertile Males". Our institution is especially well positioned to contribute to the newest initiated network-wide study, "The Evaluation of the Luteal Phase in Fertile and Infertile Women" because the faculty at Baylor is responsible for 3 hospitals (1 public; 2 private) in the nation's largest concentration of health care facilities-the Texas Medical Center. In part, for this reason, the ectopic pilot study initiated only 6 weeks ago, is already 40 percent completed and ahead of the recruitment schedule. In addition, one of the largest male reproductive units (Dr. Larry Lipshultz) complements our 3 Reproductive Endocrinologists, 2 Reproductive Geneticists, and 4 Gynecologists. Our experience in the Reproductive Medical Network has enabled us to collaborate with the other clinical centers and data collection center in designing prospective clinical trials to test hypothesis relevant to clinical medicine. We acknowledge and accept first hand the loss of autonomy necessary to represent the collective wisdom of the several institutions participating in a multicenter effort. However, the gains are substantial to the scientific community -and long awaited in our field in particular.

技术进步允许早期，非外科诊断异位妊娠的诊断促使对异位妊娠的药物治疗开始。 医疗方案在没有功效评估或严格标准的局限性方面开始普及。 1999年5月，生殖医学网络启动了一种试点方案，与1）比较单剂量甲氨蝶呤和多剂量甲氨蝶呤在异位妊娠治疗方面的功效； 2）确定每种方案的使用限制。 该应用程序的主要研究人员是该项目的前瞻性随机试验的主要作者，该项目非常适合多中心网络，因为它对公共卫生的重要性及其对大量受试者的需求，因为预期的有效性较小。作为生殖医学网络成员已有10年的历史，首席研究员和共同投资者在两个完成的网络研究中扮演着重要角色。 我们为该项目贡献了225名受试者，即总数的24％，即“对无法解释的不育症的随机治疗”，其中32％的妊娠。 招募了一个可比的数量来进行“评估肥沃男性的精液参数”。 我们的机构尤其有效地为最新的启动网络范围内的研究做出贡献：“肥沃和不育妇女的黄体阶段的评估”，因为贝勒的教师在美国最大的卫生保健机构中造成了3家医院（1名公立; 2个私立性）。 在某种程度上，因此，仅6周前就开始了40％的招聘时间表。 此外，最大的男性生殖单位之一（Larry Lipshultz博士）补充了我们的3位生殖内分泌学家，2位生殖遗传学家和4位妇科医生。我们在生殖医学网络中的经验使我们能够与其他临床中心和数据收集中心合作设计前瞻性临床试验，以检验与临床医学相关的假设。 我们承认并接受第一手的自主权丧失，以代表参与多中心努力的几个机构的集体智慧。 但是，对于科学界而言，收益是可观的，尤其是在我们领域期待的。