Research question

Does the fertility-enhancing effect of tubal flushing during hysterosalpingography (HSG) with oil-based contrast change over time?

Design

This was a secondary analysis of the H2Oil (long-term follow-up) study, a multicentre randomized controlled trial evaluating the effectiveness of oil-based and water-based contrast during HSG. The main outcome was ongoing pregnancy. Cox proportional hazards models for time to ongoing pregnancy were fitted over 3 years of follow-up.

Results

Data on 1107 couples were available; 550 couples had oil-based contrast and 557 water-based contrast at HSG. Ongoing pregnancy rates after 3 years were 77% and 71%, respectively. Median follow-up was 9–10 months (5th—95th percentile: <1 to 36). The hazard ratio for ongoing pregnancy for oil versus water over 3 years of follow-up was 1.26 (95% confidence interval [CI] 1.10–1.45). The scaled Schoenfeld residual plots showed a decrease in hazard ratio that was linear with log-transformed time. After including an interaction with log-transformed time, the hazard ratio immediately after HSG was 1.71 (95% CI 1.27–2.31) and reduced to no effect (hazard ratio of 1) at approximately 2 years. There was no evidence for a change in hazard ratio over time in a subgroup of women who experienced pain during HSG.

Conclusions

The hazard ratio for ongoing pregnancy of oil-based versus water-based contrast was 1.71 immediately after HSG, gradually decreasing and plateauing towards a hazard ratio of 1 (indicating no effect) after approximately 2 years. This supports the hypothesis that oil-based contrast might dislodge debris or mucus plugs from the Fallopian tubes, but this has yet to be definitively proved.

中文翻译：

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油基造影剂子宫输卵管造影的生育增强效果能持续多久？

研究问题

使用油基造影剂进行子宫输卵管造影 (HSG) 期间输卵管冲洗的生育力增强效果是否会随时间变化？

设计

这是 H2Oil（长期随访）研究的二次分析，这是一项多中心随机对照试验，评估 HSG 期间油基和水基对比剂的有效性。主要结果是持续妊娠。在 3 年的随访中拟合了持续妊娠时间的 Cox 比例风险模型。

结果

可获得 1107 对夫妇的数据；550 对夫妇在 HSG 有油性对比和 557 水对比。3 年后的持续妊娠率分别为 77% 和 71%。中位随访时间为 9-10 个月（第 5-95 个百分位数：<1 至 36）。3 年随访期间，油与水持续妊娠的风险比为 1.26（95% 置信区间 [CI] 1.10–1.45）。缩放的 Schoenfeld 残差图显示风险比的降低与对数转换时间呈线性关系。包括与对数转换时间的相互作用后，HSG 后立即的风险比为 1.71（95% CI 1.27–2.31），并在大约 2 年时降低至无影响（风险比为 1）。在 HSG 期间经历疼痛的女性亚组中，没有证据表明风险比随时间发生变化。

结论

油基对比水基对比剂的持续妊娠风险比在 HSG 后立即为 1.71，在大约 2 年后逐渐降低并趋于稳定，风险比为 1（表明没有影响）。这支持了油基造影剂可能会从输卵管中去除碎屑或粘液栓的假设，但这尚未得到明确证实。