Crosignani P G, Walters D E, Soliani A
II Department of Obstetrics and Gynaecology, University of Milan, Italy.
Hum Reprod. 1991 Aug;6(7):953-8. doi: 10.1093/oxfordjournals.humrep.a137468.
Nineteen European fertility centres participated in a controlled randomized trial aimed at comparing the effectiveness of five methods for the treatment of unexplained infertility. Each centre was invited to employ two of the five treatments being investigated, and the treatment allocated to individual patients was then decided by randomization. The treatments were superovulation alone, and superovulation together with one of the following procedures: intra-uterine insemination (IUI), intra-peritoneal insemination (IPI), gamete intra-Fallopian transfer (GIFT), in-vitro fertilization (IVF). All the patients admitted to the study had experienced greater than 36 months infertility prior to the start of the trial, and only patients less than 38 years of age were included in the investigation. Further, the study was confined to patients with normal Fallopian tubes, and where there was evidence of spontaneous ovulation. Yet another prerequisite for inclusion in the study was that the male partner was 'normal' as regards fertility. Due to unavoidable practical difficulties, the experimental design eventually obtained was severely unbalanced. Nevertheless, objective statistical comparisons were possible among the five treatments, using non-orthogonal analyses of variance. By the completion of the trial 444 patients had been treated in a total of 649 cycles. There was some statistical evidence that the pregnancy rate obtained from superovulation alone was inferior to that obtained by using superovulation together with one of the methods of assisted conception.(ABSTRACT TRUNCATED AT 250 WORDS)
19个欧洲生育中心参与了一项对照随机试验,旨在比较五种治疗不明原因不孕症方法的有效性。每个中心被邀请采用正在研究的五种治疗方法中的两种,然后通过随机化来决定分配给个体患者的治疗方法。这些治疗方法分别是单纯超排卵,以及超排卵结合以下程序之一:宫内人工授精(IUI)、腹腔内人工授精(IPI)、配子输卵管内移植(GIFT)、体外受精(IVF)。所有纳入该研究的患者在试验开始前不孕时间超过36个月,且仅纳入年龄小于38岁的患者。此外,该研究仅限于输卵管正常且有自发排卵证据的患者。纳入该研究的另一个前提条件是男性伴侣在生育能力方面“正常”。由于不可避免的实际困难,最终获得的实验设计严重失衡。尽管如此,使用非正交方差分析对这五种治疗方法进行客观的统计比较仍是可能的。到试验结束时,共有649个周期对444名患者进行了治疗。有一些统计证据表明,单纯超排卵的妊娠率低于超排卵结合一种辅助受孕方法的妊娠率。(摘要截短于250字)