CLOMIPHENE AND TAMOXIFEN IN OLIGOSPERMIC INFERTILITY

本研究将评估抗雌激素药物克罗米酚的疗效 柠檬酸盐（CC）和他莫昔芬（TX），在治疗少精子症男性 不孕 本议定书旨在确立和/或重申：1） CC和TX在改善精子数量、形态和活力方面的功效; 2)精子穿透试验（SPA）和牛粘液 渗透试验（BMPT）作为直接评估潜在性的手段 响应CC或TX的精子功能能力的改善：3） 接受治疗的少精子症男性女性队列的妊娠率比较 与CC，TX或安慰剂; 4）筛选和选择指南 最有可能对药物治疗有反应的少精子男性; 5） 早期预测药物治疗后续反应指南 在少精症男性中。 男性受试者及其女性伴侣将经历完全不育 评价。 对于不孕不育的主要因素是 似乎是正常促性腺激素少精子症（平均精子密度5-20 100万/毫升，每次射精的精子总数低于6000万， 2个或更多精液标本的基础上），抗雌激素治疗， 提供给满足统一筛选标准的男性。 本议定书 采用改良的双盲设计， 格式. 从那些合格并给予知情同意的男性中， 将以双盲方式随机选择组。 第1组（n=10） 将接受安慰剂治疗9个月。 第2组（n=30）将接受初始 3个月的安慰剂，随后6个月的CC 50 mg/天。 第3组（n=30） 将接受安慰剂治疗3个月，随后接受TX 20 mg/天治疗6个月。 所有组将在12个月的观察期结束时， 停药间期。 丈夫精子人工授精（AIH） 在12个月的围排卵期进行2或3次 研究间隔。 将在以下时间评估对安慰剂或活性药物的应答： 3个月间隔，利用精子功能能力的直接测量 (SPA、BMPT）、精液分析（计数、活力、形态）、内分泌 参数（FSH，睾酮）和妊娠率。

This study will evaluate the efficacy of the anti-estrogens, clomiphene citrate (CC) and tamoxifen (TX), in the treatment of oligospermic male infertility. This protocol seeks to establish and/or reaffirm; 1) the efficacy of CC and TX in improving sperm number, morphology, and motility; 2) usefulness of the sperm penetration assay (SPA) and the bovine mucus penetration test (BMPT) as means of directly assessing potential improvement in the functional capacity of sperm in response to CC or TX: 3) comparative pregnancy rates in female cohorts of oligospermic males treated with CC, TX or placebo; 4) guidelines for the screening and selection of oligospermic males who are most likely to respond to drug therapy; 5) guidelines for the early prediction of subsequent response to drug therapy in oligospermic males. Male subjects and their female partners will undergo complete infertility evaluations. For couples in whom the primary factor for infertility appears to be normogonadotropic oligospermia (mean sperm density 5-20 million/ml with total sperm count less than 60 million per ejaculate on the basis of 2 or more semen specimens), anti-estrogen therapy that will be offered to men satisfying uniform screening criteria. This protocol employs a modified double-blind design with a parallel, placebo-controlled format. From those men qualifying and giving informed consent, three groups will be randomly selected in a double-blind fashion. Group 1 (n=10) will receive placebo for 9 months. Group 2 (n=30) will receive an initial 3 months of placebo, followed by 6 months of CC 50 mg/day. Group 3 (n=30) will receive placebo for 3 months, followed by TX 20 mg/day for 6 months. All groups will conclude their 12 month observation period with a 3 month drug-free interval. Artificial insemination with husband sperm (AIH) will be performed 2 or 3 times in the periovulatory period for the 12 month study interval. The response to placebo or active drug will be assessed at 3 month intervals utilizing direct measures of sperm functional capacity (SPA, BMPT), semen analysis (count, motility, morphology), endocrine parameters (FSH, testosterone) and pregnancy rates.