Daya S, Gunby J
Departments of Obstetrics and Gynaecology and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Hum Reprod. 1999 Sep;14(9):2207-15. doi: 10.1093/humrep/14.9.2207.
The recent availability of recombinant follicle stimulating hormone (rFSH), with its high level of purity and batch-to-batch consistency has made it an attractive alternative to urinary FSH (uFSH) for ovarian stimulation. Several trials have compared the two preparations, but none had sufficient power to detect a clinically meaningful difference in pregnancy rates. The purpose of this study was to determine the clinical pregnancy rates per started cycle by pooling data from randomized trials which compared the use of rFSH and uFSH in treatment cycles using in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). A thorough search of the literature identified 12 trials which met the inclusion criteria. In four trials, both IVF and ICSI were performed, in seven trials only IVF was performed and in one trial only ICSI was performed. Data were extracted and pooled using the principles of meta-analysis. There was no significant heterogeneity of treatment effect across the trials. The common odds ratio and the risk difference (and their 95% confidence intervals), obtained by pooling the data using a fixed effects model, were 1.20 (1.02-1.42) and 3.7% (0.5-6.9%) respectively, in favour of rFSH. The pregnancy rate with the alpha preparation of rFSH was statistically significantly higher than with uFSH in IVF cycles. The overall conclusion from this meta-analysis is that the use of rFSH in assisted reproduction is preferred over uFSH.
重组促卵泡激素（rFSH）近期已可获得，其高纯度和批次间一致性使其成为用于卵巢刺激的尿促卵泡素（uFSH）的一个有吸引力的替代物。多项试验比较了这两种制剂，但没有一项试验有足够的效能检测出妊娠率方面具有临床意义的差异。本研究的目的是通过汇总随机试验的数据来确定每个开始周期的临床妊娠率，这些随机试验比较了在体外受精（IVF）或卵胞浆内单精子注射（ICSI）治疗周期中使用rFSH和uFSH的情况。对文献进行全面检索后确定了12项符合纳入标准的试验。在4项试验中同时进行了IVF和ICSI，在7项试验中仅进行了IVF，在1项试验中仅进行了ICSI。数据按照荟萃分析的原则进行提取和汇总。各试验间治疗效果不存在显著异质性。使用固定效应模型汇总数据得到的共同比值比和风险差异（及其95%置信区间）分别为1.20（1.02 - 1.42）和3.7%（0.5 - 6.9%），支持rFSH。在IVF周期中，rFSH的α制剂的妊娠率在统计学上显著高于uFSH。该荟萃分析的总体结论是，在辅助生殖中使用rFSH优于uFSH。
