The ESHRE multicentre trial on the treatment of unexplained infertility: a preliminary report. European Society of Human Reproduction and Embryology. Fallopian tube sperm perfusion has no advantage over intra-uterine insemination when used in combination with ovarian stimulation for the treatment of unexplained infertility.
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) In this prospective randomized study we treated 60 couples with unexplained infertility with a combination of ovarian stimulation and either intrauterine insemination (IUI) or fallopian sperm perfusion (FSP). In the IUI we used a volume of 0.5 ml of inseminate and in the FSP a volume of 4 ml. The demographic characteristics of the patients, the stimulation parameters and the sperm data were not statistically different between the two groups. The pregnancy rate per cycle was 16.2% in the IUI group and 14.5% in the FSP group and the pregnancy rate per woman was 40 and 36.7%, respectively (not statistically different). We conclude that IUI and FSP are equally effective in the treatment of couples with unexplained infertility.
There is insufficient evidence to suggest that oral agents are inferior or superior to injectable agents in the treatment of unexplained subfertility. Information on harms is sketchy, and remains compatible with large differences in either direction. Much larger trials than have previously been undertaken are required to provide information on relative harms as well as benefits.