Mohiyiddeen Lamiya, Hardiman Anne, Fitzgerald Cheryl, Hughes Edward, Mol Ben Willem J, Johnson Neil, Watson Andrew
St Mary's Hospital, Oxford Road, Manchester, UK, M13 9WL.
Cochrane Database Syst Rev. 2015 May 1;2015(5):CD003718. doi: 10.1002/14651858.CD003718.pub4.
Establishing the patency of the fallopian tubes is a commonly undertaken diagnostic investigation for women with subfertility. This is usually achieved by flushing contrast medium through the tubes and taking radiographs. However, it has been noted that many women conceive in the first three to six months after the tubal flushing, which has raised the possibility that tubal flushing could also be a treatment for infertility. There has been debate about which contrast medium should be used (water-soluble or oil-soluble media) as this may influence pregnancy rates.
To evaluate the effect of flushing fallopian tubes with oil- or water-soluble contrast media on live birth and pregnancy rates in women with subfertility.
We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of trials, MEDLINE, EMBASE, Biological Abstracts, trial registers and reference lists of identified articles. The most recent search was conducted in June 2014.
Randomised controlled trials (RCTs) comparing tubal flushing with oil-soluble or water-soluble contrast media, or with no treatment, in women with subfertility.
Two authors independently selected the trials, assessed risk of bias and extracted data. We contacted study authors for additional information. The overall quality of the evidence was assessed using GRADE methods.
Thirteen trials involving 2914 women were included, of whom 2494 were included in the analysis. Oil-soluble contrast media (OSCM) versus no interventionThe OSCM group had a higher rate of live birth (odds ratio (OR) 3.09, 95% CI 1.39 to 6.91, 1 RCT, 158 women, low quality evidence) and ongoing pregnancy (OR 3.59, 95% CI 2.06 to 6.26, 3 RCTs, 382 women, I(2) = 0%, low quality evidence) than women who had no intervention. Our findings suggest that among subfertile women with a 17% chance of an ongoing pregnancy if they have no intervention, the rate will increase to between 29% and 55% if they have tubal flushing with OSCM. Water-soluble contrast media (WSCM) versus no interventionThere was no evidence of a difference between the groups in rates of live birth (OR 1.13, 95% CI 0.67 to 1.91, 1 RCT, 334 women, very low quality evidence) or ongoing pregnancy (OR 1.14, 95% CI 0.71 to 1.84, 1 RCT, 334 women, very low quality evidence). OSCM versus WSCMTwo RCTs reported live birth: one found a higher live birth rate in the oil-soluble group and the other found no evidence of a difference between the groups. These studies were not pooled due to very high heterogeneity (I(2) = 93%). There was no evidence of a difference between the groups in rates of ongoing pregnancy, however there was high heterogeneity (OR 1.44, 95% CI 0.84 to 2.47, 5 RCTs, 1454 women, I(2) = 76%, random-effects model, very low quality evidence). OSCM plus WSCM versus WSCM aloneThere was no evidence of a difference between the groups in rates of live birth (OR 1.06, 95% CI 0.64 to 1.77, 1 RCT, 393 women, very low quality evidence) or ongoing pregnancy (OR 1.23, 95% CI 0.87 to 1.72, 4 RCTs, 633 women, I(2) = 0%, low quality evidence).There was no evidence of a difference between any of the interventions in rates of adverse events, but such events were poorly reported in most studies.
AUTHORS' CONCLUSIONS: The evidence suggests that tubal flushing with oil-soluble contrast media may increase the chance of pregnancy and live birth compared to no intervention. Findings for other comparisons were inconclusive due to inconsistency and lack of statistical power. There was insufficient evidence on adverse events to reach firm conclusions. Further robust randomised controlled trials are needed.
对于不孕女性,确定输卵管通畅性是一项常见的诊断性检查。这通常通过向输卵管内注入造影剂并拍摄X光片来实现。然而,有人注意到许多女性在输卵管通液后的头三到六个月内怀孕,这增加了输卵管通液也可能是一种治疗不孕症方法的可能性。关于应使用哪种造影剂(水溶性或油溶性介质)存在争议,因为这可能会影响妊娠率。
评估使用油溶性或水溶性造影剂冲洗输卵管对不孕女性活产率和妊娠率的影响。
我们检索了Cochrane月经失调与不孕专业试验注册库、MEDLINE、EMBASE、生物学文摘数据库、试验注册库以及已识别文章的参考文献列表。最近一次检索于2014年6月进行。
比较输卵管通液使用油溶性或水溶性造影剂,或不进行治疗的随机对照试验(RCT),研究对象为不孕女性。
两位作者独立选择试验、评估偏倚风险并提取数据。我们联系研究作者获取更多信息。使用GRADE方法评估证据的总体质量。
纳入了13项试验,涉及2914名女性,其中2494名纳入分析。油溶性造影剂(OSCM)与不干预相比:OSCM组的活产率(优势比(OR)3.09,95%置信区间1.39至6.91,1项RCT,158名女性,低质量证据)和持续妊娠率(OR 3.59,95%置信区间2.06至6.26,3项RCT,382名女性,I² = 0%,低质量证据)高于未干预的女性。我们的研究结果表明,在未干预时持续妊娠几率为17%的不孕女性中,如果进行OSCM输卵管通液,该几率将增至29%至55%。水溶性造影剂(WSCM)与不干预相比:两组在活产率(OR 1.13,95%置信区间0.67至1.91,1项RCT,334名女性,极低质量证据)或持续妊娠率(OR 1.14,95%置信区间0.71至1.84,1项RCT,334名女性,极低质量证据)方面无差异证据。OSCM与WSCM相比:两项RCT报告了活产情况:一项发现油溶性组的活产率更高,另一项未发现两组之间存在差异的证据。由于异质性非常高(I² = 93%),这些研究未进行合并。两组在持续妊娠率方面无差异证据,但异质性较高(OR 1.44,95%置信区间0.84至2.47,5项RCT,1454名女性,I² = 76%,随机效应模型,极低质量证据)。OSCM加WSCM与单独使用WSCM相比:两组在活产率(OR 1.06,95%置信区间0.64至1.77,1项RCT,393名女性,极低质量证据)或持续妊娠率(OR 1.23,95%置信区间0.87至1.72,4项RCT,633名女性,I² = 0%,低质量证据)方面无差异证据。各干预措施在不良事件发生率方面均无差异证据,但大多数研究对不良事件的报告较差。
证据表明,与不干预相比,使用油溶性造影剂进行输卵管通液可能会增加妊娠和活产的机会。其他比较的结果因不一致性和缺乏统计效力而不确定。关于不良事件的证据不足,无法得出明确结论。需要进一步开展有力的随机对照试验。