Soliman S, Daya S, Collins J, Jarrell J
Department of Obstetrics and Gynaecology, McMaster University, Hamilton, Ontario, Canada.
Fertil Steril. 1993 Jun;59(6):1239-44. doi: 10.1016/s0015-0282(16)55983-4.
To evaluate the effectiveness of IVF in couples with infertility.
Two hundred forty-five consecutive couples with infertility were randomized to receive one cycle of IVF treatment (experimental group) or to wait for a period of 6 months before receiving IVF treatment, during which time other infertility treatments could have been undertaken (control group).
Patients were referred to the Fertility Clinic at Chedoke-McMaster Hospitals, a university-associated institution in Hamilton, Ontario, Canada, in which IVF has been offered to couples since 1984.
Couples with infertility (mean duration of 65 months) not corrected by conventional treatment. They came from all socioeconomic classes, and the costs of IVF treatment, except medication, were covered by the Ontario Health Insurance Plan.
Pregnancy was confirmed by ultrasound documentation of a gestational sac or histologic examination of tissue. Outcomes included livebirth, spontaneous abortion, and ectopic pregnancy. The overall pregnancy rate (PR) and the interval-to-pregnancy duration were compared in each group.
Univariate analysis demonstrated a significant beneficial effect of IVF treatment in patients with bilateral severe tubal disease. Although in other diagnostic categories the crude and cumulative PRs in the experimental group were higher than in the control group, the differences did not reach statistical significance. Among the early IVF group, those with endometriosis had significantly more pregnancies when compared with other diagnostic categories. Although IVF increases the likelihood of pregnancy by 40% with severe tubal disease, the overall 31% increase associated with IVF was not statistically significant.
There was a significant difference in favor of treatment in patients with severe bilateral tubal disease. For couples with other causes of infertility, the confidence limits around the treatment effect included unity. To reject the null hypothesis of no treatment effect, a larger sample size or a meta-analysis to combine the results of similar trials is required.
评估体外受精（IVF）对不孕夫妇的有效性。
245对连续的不孕夫妇被随机分为两组，一组接受一个周期的IVF治疗（实验组），另一组等待6个月后再接受IVF治疗，在此期间可进行其他不孕治疗（对照组）。
患者被转诊至加拿大安大略省汉密尔顿市与大学相关的切多克-麦克马斯特医院的生育诊所，自1984年起该诊所就为夫妇提供IVF治疗。
经传统治疗未得到改善的不孕夫妇（平均不孕时长65个月）。他们来自所有社会经济阶层，IVF治疗费用（药物除外）由安大略省医疗保险计划支付。
通过超声检查妊娠囊或组织的组织学检查确认妊娠。结局包括活产、自然流产和异位妊娠。比较每组的总体妊娠率（PR）和妊娠间隔时间。
单因素分析表明，IVF治疗对双侧严重输卵管疾病患者有显著的有益效果。尽管在其他诊断类别中，实验组的粗妊娠率和累积妊娠率高于对照组，但差异未达到统计学显著性。在早期IVF组中，患有子宫内膜异位症的患者与其他诊断类别相比，妊娠次数显著更多。尽管对于严重输卵管疾病患者，IVF使妊娠可能性增加了40%，但与IVF相关的总体31%的增加无统计学显著性。
对于双侧严重输卵管疾病患者，治疗组有显著差异。对于其他原因导致不孕的夫妇，治疗效果的置信区间包含1。要拒绝无治疗效果的零假设，需要更大的样本量或进行荟萃分析以合并类似试验的结果。
