CLOMIPHENE AND TAMOXIFEN IN OLIGOSPERMIC INFERTILITY

这项研究将评估抗雌激素药物克罗米芬的疗效。 柠檬酸(CC)联合他莫昔芬(TX)治疗少精子症 不孕不育。本议定书旨在确立和/或重申：1) CC和TX在改善精子数量、形态和活力方面的效果； 2)精子穿透试验(SPA)和牛粘液的有用性 渗透试验(BMPT)作为直接评估潜力的手段 CC或TX：3对精子功能的改善 接受治疗的少精子症男性的女性队列中的妊娠率比较 使用CC、TX或安慰剂；4)筛选和选择 最有可能对药物治疗有反应的少精子症男性；5) 药物治疗后续反应的早期预测指南 在少精子症男性身上。 男性受试者和他们的女性伴侣将经历完全不育 评估。对于那些将不孕的主要因素 似乎是促性腺激素正常的少精子症(平均精子密度为5-20 每射精液精子总数低于6000万个/毫升 根据2个或更多精液样本)，将进行抗雌激素治疗 提供给符合统一筛查标准的男性。该协议 采用改进的双盲设计，采用平行的安慰剂对照 格式化。在那些有资格并给予知情同意的男子中，有三人 分组将以双盲方式随机选择。第1组(10例) 将接受9个月的安慰剂治疗。组2(n=30)将收到首个 服用3个月的安慰剂，然后服用6个月的CC 50 mg/d。第3组(30例) 服用安慰剂3个月，然后每天服用TX 20 mg，疗程6个月。 所有小组将以3个月结束他们12个月的观察期 戒毒间歇期。丈夫精子人工授精(AIH)将 在排卵期进行2-3次，持续12个月 学习间歇。对安慰剂或活性药物的反应将在 使用直接测量精子功能能力的3个月间隔 (SPA、BMPT)、精液分析(计数、活力、形态)、内分泌 参数(卵泡刺激素、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.