Chua Su Jen, Akande Valentine A, Mol Ben Willem J
The University of Adelaide, Adelaide, Australia, SA5005.
Obstetrics & Gynaecology, Directorate of Women's Health, Southmead Hospital, Southmead Road, Bristol, England, UK, BS10 5NB.
Cochrane Database Syst Rev. 2017 Jan 23;1(1):CD006415. doi: 10.1002/14651858.CD006415.pub3.
Surgery remains an acceptable treatment modality for tubal infertility despite the rise in usage of in vitro fertilisation (IVF). Estimated livebirth rates after surgery range from 9% for women with severe tubal disease to 69% for those with mild disease; however, the effectiveness of surgery has not been rigorously evaluated in comparison with other treatments such as IVF and expectant management (no treatment). Livebirth rates have not been adequately assessed in relation to the severity of tubal damage. It is important to determine the effectiveness of surgery against other treatment options in women with tubal infertility because of concerns about adverse outcomes, intraoperative complications and costs associated with tubal surgery, as well as alternative treatments, mainly IVF.
The aim of this review was to determine the effectiveness and safety of surgery compared with expectant management or IVF in improving the probability of livebirth in the context of tubal infertility (regardless of grade of severity).
We searched the following databases in October 2016: the Cochrane Gynaecology and Fertility (CGF) Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycINFO; as well as clinical trials registries, sources of unpublished literature and reference lists of included trials and related systematic reviews.
We considered only randomised controlled trials to be eligible for inclusion, with livebirth rate per participant as the primary outcome of interest.
We planned that two review authors would independently assess trial eligibility and risk of bias and would extract study data. The primary review outcome was cumulative livebirth rate. Pregnancy rate and adverse outcomes, including miscarriage rate, rate of ectopic pregnancy and rate of procedure-related complications, were secondary outcomes. We planned to combine data to calculate pooled odds ratios (ORs) and 95% confidence intervals (CIs). We planned to assess statistical heterogeneity using the I2 statistic and to assess the overall quality of evidence for the main comparisons using GRADE methods.
We identified no suitable randomised controlled trials.
AUTHORS' CONCLUSIONS: The effectiveness of tubal surgery relative to expectant management and IVF in terms of livebirth rates for women with tubal infertility remains unknown. Large trials with adequate power are warranted to establish the effectiveness of surgery in these women. Future trials should not only report livebirth rates per patient but should compare adverse effects and costs of treatment over a longer time. 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 be considered. Researchers should report livebirth rates in relation to severity of tubal damage and different techniques used for tubal repair, including microsurgery and laparoscopic methods.
尽管体外受精（IVF）的使用有所增加，但手术仍是输卵管性不孕可接受的治疗方式。手术后的估计活产率从患有严重输卵管疾病的女性的9%到患有轻度疾病的女性的69%不等；然而，与其他治疗方法如IVF和期待管理（不治疗）相比，手术的有效性尚未得到严格评估。活产率尚未根据输卵管损伤的严重程度进行充分评估。由于担心不良后果、术中并发症以及与输卵管手术相关的成本，以及替代治疗方法（主要是IVF），确定输卵管性不孕女性手术相对于其他治疗选择的有效性很重要。
本综述的目的是确定在输卵管性不孕（无论严重程度如何）的情况下，与期待管理或IVF相比，手术在提高活产概率方面的有效性和安全性。
我们于2016年10月检索了以下数据库：Cochrane妇科与生育（CGF）组试验注册库、Cochrane对照试验中央注册库（CENTRAL）、MEDLINE、Embase、护理及相关健康文献累积索引（CINAHL）和PsycINFO；以及临床试验注册库、未发表文献来源以及纳入试验和相关系统评价的参考文献列表。
我们仅考虑随机对照试验有资格纳入，将每位参与者的活产率作为主要关注结果。
我们计划由两位综述作者独立评估试验的资格和偏倚风险，并提取研究数据。主要综述结果为累积活产率。妊娠率和不良结局，包括流产率、宫外孕率和手术相关并发症率，为次要结局。我们计划合并数据以计算合并比值比（OR）和95%置信区间（CI）。我们计划使用I²统计量评估统计异质性，并使用GRADE方法评估主要比较的总体证据质量。
我们未找到合适的随机对照试验。
输卵管性不孕女性输卵管手术相对于期待管理和IVF在活产率方面的有效性仍然未知。需要进行有足够效力的大型试验来确定手术对这些女性的有效性。未来的试验不仅应报告每位患者的活产率，还应比较更长时间内的治疗不良反应和成本。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。研究人员应报告与输卵管损伤严重程度以及用于输卵管修复的不同技术（包括显微手术和腹腔镜方法）相关的活产率。
