COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK

协作多中心生殖医学网络

• 批准号: 3566292
• 负责人: ALAN H. DECHERNEY
• 金额: $ 2.51万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-05-15 至 1995-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3566292
• 关键词: clinical trials; clomiphene; cooperative study; female reproductive system disorder diagnosis; fertility; fertility promoting drug; human pregnant subject; human subject; reproductive system disorder chemotherapy

A proposal to study the effects of clomiphene citrate on fertility in normal cycling women. Clomiphene is widely used to stimulate fertility. As indicated in the RFA for the Network, this treatment is applied without normative data for evaluating efficacy, often without established diagnoses and is expensive of time, psychological reserves and money. In fact, evidence indicates that clomiphene may actually impair fertility; therefore, its use for treatment may be counter-productive in marginal cases. We propose to study normal volunteers (defined as up to 7 months unprotected intercourse without pregnancy) in order to establish normative data for pregnancy rates, and to assess the effect of clomiphene treatment on the pregnancy rate. The experimental protocol is constructed upon the randomized, double-blind crossover model. Normative data will be obtained during the "drug washout" and placebo periods. This study has particular relevance for the RFA in fight of its direct applicability to the diagnosis and treatment of infertility, the common but unsubstantiated usage of clomiphene under these conditions, and the need for a study population which can best be obtained through the Cooperative Network.

研究克罗米芬对生育力影响的建议 骑自行车的正常女性克罗米酚被广泛用于刺激生育。作为 在网络的RFA中指出，这种治疗方法的应用， 用于评价疗效的规范性数据，通常没有确定的诊断 而且耗费时间、心理储备和金钱。事实上，我想， 有证据表明，克罗米酚实际上可能损害生育能力; 因此，它用于治疗可能会产生反作用， 例我们建议研究正常志愿者（定义为长达7个月 无保护性交而不怀孕），以建立规范的 妊娠率的数据，并评估克罗米酚治疗的效果 对怀孕率的影响实验方案是基于 随机双盲交叉模型。将获得规范性数据 在“药物洗脱期”和安慰剂期。这项研究特别 RFA与其直接适用于诊断的相关性 和治疗不孕症，常见的，但未经证实的使用， 克罗米酚在这些条件下，并需要一个研究人口 这可以通过合作网络最好地获得。