Pandian Z, Bhattacharya S, Nikolaou D, Vale L, Templeton A
Obstetrics & Gynaecology, University of Aberdeen, Aberdeen Maternity Hospital, Cornhill Road, Aberdeen, UK, AB25 2ZD.
Cochrane Database Syst Rev. 2002(2):CD003357. doi: 10.1002/14651858.CD003357.
In vitro fertilisation (IVF) is now a widely accepted treatment for unexplained infertility (RCOG 1998). However, with estimated livebirth rates per cycle varying between 13% and 28%, it's effectiveness has not been rigorously evaluated in comparison with other treatments. With increasing awareness of the role of expectant management and less invasive procedures such as intrauterine insemination, concerns about multiple complications and costs associated with IVF, it is extremely important to evaluate the effectiveness of IVF against other treatment options in couples with unexplained infertility.
The aim of this review is to determine, in the context of unexplained infertility, whether IVF improves the probability of livebirth compared with 1. expectant management 2. clomiphene citrate (CC) 3. intra uterine insemination (IUI) alone 4. IUI with controlled ovarian stimulation and 5. Gamete IntraFallopian Transfer (GIFT).
RCTs were identified using the search strategies developed for the Menstrual Disorders and Subfertility Group. See Review group for more information.
Only randomised controlled trials were included. Livebirth rate per woman was the primary outcome of interest.
Two reviewers independently assessed eligibility and quality of trials.
Nine randomised controlled trials were identified. In two we could not extract data separately for unexplained infertility cases, two were non-randomised, one reported no valid rates (included in the review and not in the meta-analysis), leaving four trials for analysis. One trial compared two different interventions (IVF versus IUI with or without ovarian stimulation) and one study compared three interventions (IVF versus IUI with ovarian stimulation and GIFT). The number of trials assessing the effectiveness of IVF with the other treatments were as follows: IVF versus expectant management (one), IVF versus IUI (one), IVF versus IUI with ovarian stimulation (two) and IVF versus GIFT (three). Livebirth rate per woman was reported in two studies and three studies determined clinical pregnancy rate per woman. Multiple pregnancy rate was reported in three trials. Two studies reported ovarian hyperstimulation syndrome (OHSS) as an outcome measure. There were no comparative data for clomiphene citrate, and no comparative data on livebirth rates for expectant management or GIFT. There was no evidence of a difference in livebirth rates between IVF and IUI either without (OR 0.51, 95% CI 0.23 to 1.1) or with (OR 0.87, 95% CI 0.42 to 1.8) ovarian stimulation. There was no evidence of a difference in clinical pregnancy rates between IVF and expectant management. There was no significant difference in the clinical pregnancy rates between IVF and GIFT (OR 0.47, 95% CI 0.24 to 0.92). There was no evidence of a difference in the multiple pregnancy rates between IVF and either IUI with ovarian stimulation (OR 1.59, 95% CI 0.68 to 3.70) or GIFT (OR 0.47, 95% CI 0.08 to 0.58). Clinical heterogeneity was present among the studies included. However, there was no evidence of statistical heterogeneity, which allowed the studies to be combined for statistical analysis.
REVIEWER'S CONCLUSIONS: Any effect of IVF relative to expectant management, clomiphene citrate, IUI with or without ovarian stimulation and GIFT in terms of livebirth rates for couples with unexplained subfertility remains unknown. The studies included are limited by their small sample size, so that even large differences might be hidden. Livebirth rates are seldom reported. Adverse effects such as multiple pregnancies and ovarian hyperstimulation syndrome have also not been reported in most studies. Larger trials with adequate power are warranted to establish the effectiveness of IVF in these women. Future trials should not only report rates per woman /couple but also include adverse effects and costs of the treatments compared as outcomes. Factors that have a major effect on these outcomes such as fertility treatment, female partner's age, duration of infertility and previous pregnancy history should also be considered.
体外受精（IVF）如今是一种被广泛接受的治疗不明原因不孕症的方法（英国皇家妇产科医师学院，1998年）。然而，每个周期的估计活产率在13%至28%之间，与其他治疗方法相比，其有效性尚未得到严格评估。随着对期待管理作用的认识不断提高，以及诸如宫内授精等侵入性较小的程序的出现，人们对IVF相关的多种并发症和成本也越来越关注，因此评估IVF与其他治疗方案相比对不明原因不孕症夫妇的有效性极其重要。
本综述的目的是在不明原因不孕症的背景下，确定与以下治疗方法相比，IVF是否能提高活产概率：1. 期待管理；2. 枸橼酸氯米芬（CC）；3. 单纯宫内授精（IUI）；4. 控制性卵巢刺激下的IUI；5. 配子输卵管内移植（GIFT）。
使用为月经紊乱与亚生育组制定的检索策略来识别随机对照试验。更多信息见综述组。
仅纳入随机对照试验。每位女性的活产率是主要关注的结局。
两名综述员独立评估试验的合格性和质量。
共识别出9项随机对照试验。其中两项我们无法分别提取不明原因不孕症病例的数据，两项为非随机试验，一项未报告有效率（纳入综述但未纳入荟萃分析），剩下四项试验用于分析。一项试验比较了两种不同干预措施（IVF与有或无卵巢刺激的IUI），一项研究比较了三种干预措施（IVF与有卵巢刺激的IUI及GIFT）。评估IVF与其他治疗方法有效性的试验数量如下：IVF与期待管理（一项）、IVF与IUI（一项）、IVF与有卵巢刺激的IUI（两项）以及IVF与GIFT（三项）。两项研究报告了每位女性的活产率，三项研究确定了每位女性的临床妊娠率。三项试验报告了多胎妊娠率。两项研究将卵巢过度刺激综合征（OHSS）作为结局指标进行了报告。没有关于枸橼酸氯米芬的比较数据，也没有关于期待管理或GIFT活产率的比较数据。无论有无卵巢刺激，IVF与IUI之间的活产率均无差异（比值比0.51，95%置信区间0.23至1.1）或有卵巢刺激时（比值比0.87，95%置信区间0.42至1.8）。IVF与期待管理之间的临床妊娠率无差异。IVF与GIFT之间的临床妊娠率无显著差异（比值比0.47，95%置信区间0.24至0.92）。IVF与有卵巢刺激的IUI（比值比1.59，95%置信区间0.68至3.70）或GIFT（比值比0.47，95%置信区间0.08至0.58）之间的多胎妊娠率均无差异。纳入的研究存在临床异质性。然而，没有统计学异质性的证据，这使得这些研究能够合并进行统计分析。
对于不明原因不孕症夫妇，IVF相对于期待管理、枸橼酸氯米芬、有或无卵巢刺激的IUI以及GIFT在活产率方面的任何效果仍不清楚。纳入的研究受样本量小的限制，以至于即使存在较大差异也可能被掩盖。活产率很少被报告。大多数研究也未报告多胎妊娠和卵巢过度刺激综合征等不良反应。有必要进行更大规模、有足够效力的试验来确定IVF对这些女性的有效性。未来试验不仅应报告每位女性/夫妇的比率，还应将比较的治疗方法的不良反应和成本作为结局纳入。还应考虑对这些结局有重大影响的因素，如生育治疗、女性伴侣年龄、不孕持续时间和既往妊娠史。
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