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不明原因的亚生育力的宫内人工授精

Intra-uterine insemination for unexplained subfertility.

作者信息

Veltman-Verhulst Susanne M, Cohlen Ben J, Hughes Edward, Heineman Maas Jan

机构信息

University Medical Center Utrecht, Department of Reproductive Medicine and Gynecology, Utrecht, Netherlands.

出版信息

Cochrane Database Syst Rev. 2012 Sep 12(9):CD001838. doi: 10.1002/14651858.CD001838.pub4.

Abstract

BACKGROUND

Intra-uterine insemination (IUI) is a widely used fertility treatment for couples with unexplained subfertility. Although IUI is less invasive and less expensive than in vitro fertilisation (IVF), the safety of IUI in combination with ovarian hyperstimulation (OH) is debated. The main concern about IUI treatment with OH is the increase in multiple pregnancy rate.

OBJECTIVES

To determine whether, for couples with unexplained subfertility, IUI improves the live birth rate compared with timed intercourse (TI), both with and without ovarian hyperstimulation (OH).

SEARCH METHODS

We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (searched July 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 7), MEDLINE (1966 to July 2011), EMBASE (1980 to July 2011), PsycINFO (1806 to July 2011), SCIsearch and reference lists of articles. Authors of identified studies were contacted for missing or unpublished data.

SELECTION CRITERIA

Truly randomised controlled trials (RCTs) with at least one of the following comparisons were included: IUI versus TI, both in a natural cycle; IUI versus TI, both in a stimulated cycle; IUI in a natural cycle versus IUI in a stimulated cycle; IUI with OH versus TI in a natural cycle; IUI in a natural cycle versus TI with OH. Only couples with unexplained subfertility were included.

DATA COLLECTION AND ANALYSIS

Quality assessment and data extraction were performed independently by two review authors. Outcomes were extracted and the data were pooled. Subgroup and sensitivity analyses were done where possible.

MAIN RESULTS

One trial compared IUI in a natural cycle with expectant management and showed no evidence of increased live births (334 women: odds ratio (OR) 1.60, 95% confidence interval (CI) 0.92 to 2.8). In the six trials where IUI was compared with TI, both in stimulated cycles, there was evidence of an increased chance of pregnancy after IUI (six RCTs, 517 women: OR 1.68, 95% CI 1.13 to 2.50). A significant increase in live birth rate was found for women where IUI with OH was compared with IUI in a natural cycle (four RCTs, 396 women: OR 2.07, 95% CI 1.22 to 3.50). However the trials provided insufficient data to investigate the impact of IUI with or without OH on several important outcomes including live births, multiple pregnancies, miscarriage and risk of ovarian hyperstimulation. There was no evidence of a difference in pregnancy rate for IUI with OH compared with TI in a natural cycle (two RCTs, total 304 women: data not pooled). The final comparison of IUI in natural cycle to TI with OH showed a marginal, significant increase in live births for IUI (one RCT, 342 women: OR 1.95, 95% CI 1.10 to 3.44).

AUTHORS' CONCLUSIONS: There is evidence that IUI with OH increases the live birth rate compared to IUI alone. The likelihood of pregnancy was also increased for treatment with IUI compared to TI in stimulated cycles. One adequately powered multicentre trial showed no evidence of effect of IUI in natural cycles compared with expectant management. There is insufficient data on multiple pregnancies and other adverse events for treatment with OH. Therefore couples should be fully informed about the risks of IUI and OH as well as alternative treatment options.

摘要

背景

宫腔内人工授精(IUI)是一种广泛应用于不明原因不孕症夫妇的生育治疗方法。尽管IUI比体外受精(IVF)侵入性小且成本低,但IUI联合卵巢过度刺激(OH)的安全性仍存在争议。IUI联合OH治疗的主要担忧是多胎妊娠率增加。

目的

确定对于不明原因不孕症夫妇,IUI与自然周期性交(TI)相比,无论有无卵巢过度刺激(OH),是否能提高活产率。

检索方法

我们检索了Cochrane月经失调与不孕症小组试验注册库(2011年7月检索)、Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2011年第7期)、MEDLINE(1966年至2011年7月)、EMBASE(1980年至2011年7月)、PsycINFO(1806年至2011年7月)、SCIsearch以及文章的参考文献列表。联系已识别研究的作者获取缺失或未发表的数据。

选择标准

纳入至少有以下比较之一的真正随机对照试验(RCT):自然周期中IUI与TI比较;刺激周期中IUI与TI比较;自然周期中IUI与刺激周期中IUI比较;OH联合IUI与自然周期中TI比较;自然周期中IUI与OH联合TI比较。仅纳入不明原因不孕症夫妇。

数据收集与分析

由两位综述作者独立进行质量评估和数据提取。提取结局并合并数据。尽可能进行亚组分析和敏感性分析。

主要结果

一项试验比较了自然周期中IUI与期待管理,未显示活产增加的证据(334名女性:优势比(OR)1.60,95%置信区间(CI)0.92至2.8)。在六项将刺激周期中的IUI与TI进行比较的试验中,有证据表明IUI后怀孕几率增加(六项RCT,517名女性:OR 1.68,95%CI 1.13至2.50)。与自然周期中IUI相比,OH联合IUI的女性活产率显著增加(四项RCT,396名女性:OR 2.07,95%CI 1.22至3.50)。然而,这些试验提供的数据不足以研究有无OH的IUI对包括活产、多胎妊娠、流产和卵巢过度刺激风险等几个重要结局的影响。与自然周期中TI相比,OH联合IUI的妊娠率无差异证据(两项RCT,共304名女性:数据未合并)。自然周期中IUI与OH联合TI的最终比较显示IUI的活产有轻微显著增加(一项RCT,342名女性:OR 1.95,95%CI 1.10至3.44)。

作者结论

有证据表明,与单独IUI相比,OH联合IUI可提高活产率。与刺激周期中的TI相比,IUI治疗的妊娠可能性也增加。一项样本量充足的多中心试验显示,与期待管理相比,自然周期中IUI无效果证据。关于OH治疗的多胎妊娠和其他不良事件的数据不足。因此,应让夫妇充分了解IUI和OH的风险以及替代治疗方案。

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