Department of Reproductive Medicine, Amsterdam UMC Location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Amsterdam Reproduction and Development Research Institute, Amsterdam, The Netherlands.
Hum Reprod. 2024 Nov 1;39(11):2485-2490. doi: 10.1093/humrep/deae194.
Does hysterosalpingo-foam sonography (HyFoSy) prior to hysterosalpingography (HSG) or HSG prior to HyFoSy affect visible tubal patency when compared HSG or HyFoSy alone?
Undergoing either HyFoSy or HSG prior to tubal patency testing by the alternative method does not demonstrate a significant difference in visible tubal patency when compared to HyFoSy or HSG alone.
HyFoSy and HSG are two commonly used visual tubal patency tests with a high and comparable diagnostic accuracy for evaluating tubal patency. These tests may also improve fertility, although the underlying mechanism is still not fully understood. One of the hypotheses points to a dislodgment of mucus plugs that may have disrupted the patency of the Fallopian tubes.
STUDY DESIGN, SIZE, DURATION: This is a secondary analysis of the randomized controlled FOAM study, in which women underwent tubal patency testing by HyFoSy and HSG, randomized for order of the procedure. Participants either had HyFoSy first and then HSG, or vice versa. Here, we evaluate the relative effectiveness of tubal patency testing by HyFoSy or HSG prior to the alternative tubal patency testing method on visible tubal patency, compared to each method alone.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Infertile women aged between 18 and 41 years scheduled for tubal patency testing were eligible for participating in the FOAM study. Women with anovulatory cycles, endometriosis, or with a partner with male infertility were excluded. To evaluate the effect HyFoSy on tubal patency, we relied on HSG results by comparing the proportion of women with bilateral tubal patency visible on HSG in those who underwent and who did not undergo HyFoSy prior to their HSG (HyFoSy prior to HSG versus HSG alone). To evaluate the effect of HSG on tubal patency, we relied on HyFoSy results by comparing the proportion of women with bilateral tubal patency visible on HyFoSy in those who underwent and who did not undergo HSG prior to their HyFoSy (HSG prior to HyFoSy versus HyFoSy alone).
Between May 2015 and January 2019, we randomized 1160 women (576 underwent HyFoSy first followed by HSG, and 584 underwent HSG first followed by HyFoSy). Among the women randomized to HyFoSy prior to HSG, bilateral tubal patency was visible on HSG in 467/537 (87%) women, compared with 472/544 (87%) women who underwent HSG alone (risk difference 0.2%; 95% CI: -3.8% to 4.2%). Among the women randomized to HSG prior to HyFoSy, bilateral tubal patency was visible on HyFoSy in 394/471 (84%) women, compared with 428/486 (88%) women who underwent HyFoSy alone (risk difference -4.4%; 95% CI: -8.8% to 0.0%).
LIMITATIONS, REASONS FOR CAUTION: The results of this secondary analysis should be interpreted as exploratory and cannot be regarded as definitive evidence. Furthermore, it has to be noted that pregnancy outcomes were not considered in this analysis.
Tubal patency testing by either HyFoSy or HSG, prior to the alternative tubal patency testing method does not significantly affect visible tubal patency, when compared to alternative method alone. This suggests that both methods may have comparable abilities to dislodge mucus plugs in the Fallopian tubes.
STUDY FUNDING/COMPETING INTEREST(S): The FOAM study was an investigator-initiated study, funded by ZonMw, a Dutch organization for Health Research and Development (project number 837001504). IQ Medical Ventures provided the ExEm®-FOAM kits free of charge. The funders had no role in study design, collection, analysis, or interpretation of the data. H.R.V. reports consultancy fees from Ferring. M.v.W. received a travel grant from Oxford University Press in the role of Deputy Editor for Human Reproduction and participates in a Data Safety and Monitoring Board as an independent methodologist in obstetrics studies in which she has no other role. M.v.W. is coordinating editor of Cochrane Fertility and Gynaecology. B.W.J.M. received an investigator grant from NHMRC (GNT1176437) and research funding from Merck KGaA. B.W.J.M. reports consultancy for Organon and Merck KGaA, and travel support from Merck KGaA. B.W.J.M. reports holding stocks of ObsEva. V.M. received research grants from Guerbet, Merck and Ferring and travel and speaker fees from Guerbet. The other authors do not report conflicts of interest.
International Clinical Trials Registry Platform No. NTR4746.
在进行子宫输卵管造影术（HSG）或 HyFoSy 之前进行子宫输卵管泡沫超声造影术（HyFoSy）与单独进行 HSG 或 HyFoSy 相比，是否会影响可见的输卵管通畅性？
与单独进行 HyFoSy 或 HSG 相比，在通过替代方法进行输卵管通畅性测试之前，进行 HyFoSy 或 HSG 并不能显著增加可见的输卵管通畅性。
HyFoSy 和 HSG 是两种常用的可视化输卵管通畅性测试方法，在评估输卵管通畅性方面具有较高且相当的诊断准确性。这些测试方法也可能提高生育能力，尽管其潜在机制仍不完全清楚。一种假设指出，粘液栓的松动可能破坏了输卵管的通畅性。
研究设计、规模、持续时间：这是 FOAM 研究的二次分析，其中女性接受 HyFoSy 和 HSG 进行输卵管通畅性测试，并随机分配程序顺序。参与者要么先进行 HyFoSy，然后再进行 HSG，要么反之。在这里，我们评估了在替代输卵管通畅性测试方法之前，通过 HyFoSy 或 HSG 进行输卵管通畅性测试对可见输卵管通畅性的相对有效性，与每种方法单独进行的情况进行比较。
参与者/材料、设置、方法：年龄在 18 至 41 岁之间的计划进行输卵管通畅性测试的不孕女性有资格参加 FOAM 研究。患有无排卵周期、子宫内膜异位症或伴侣患有男性不育症的女性被排除在外。为了评估 HyFoSy 对输卵管通畅性的影响，我们依靠 HSG 结果，通过比较在 HSG 之前接受和未接受 HyFoSy 的女性中在 HSG 上可见双侧输卵管通畅的比例（HyFoSy 之前的 HSG 与单独的 HSG）。为了评估 HSG 对输卵管通畅性的影响，我们依靠 HyFoSy 结果，通过比较在 HyFoSy 之前接受和未接受 HSG 的女性中在 HyFoSy 上可见双侧输卵管通畅的比例（HSG 之前的 HyFoSy 与单独的 HyFoSy）。
2015 年 5 月至 2019 年 1 月期间，我们随机分配了 1160 名女性（576 名先进行 HyFoSy 后进行 HSG，584 名先进行 HSG 后进行 HyFoSy）。在随机分配到 HyFoSy 之前进行 HSG 的女性中，在 HSG 上可见双侧输卵管通畅的女性有 467/537（87%），而单独进行 HSG 的女性有 472/544（87%）（风险差异 0.2%；95%CI：-3.8%至 4.2%）。在随机分配到 HSG 之前进行 HyFoSy 的女性中，在 HyFoSy 上可见双侧输卵管通畅的女性有 394/471（84%），而单独进行 HyFoSy 的女性有 428/486（88%）（风险差异-4.4%；95%CI：-8.8%至 0.0%）。
局限性、谨慎原因：这一二次分析的结果应被视为探索性的，不能被视为确凿的证据。此外，还需要注意的是，本分析未考虑妊娠结局。
与单独进行替代输卵管通畅性测试方法相比，通过 HyFoSy 或 HSG 进行输卵管通畅性测试并不会显著影响可见的输卵管通畅性，这表明这两种方法可能具有相似的能力来松动输卵管中的粘液栓。
研究资金/利益冲突：FOAM 研究是一项由 ZonMw（荷兰卫生研究和发展组织）资助的由研究者发起的研究（项目编号 837001504）。IQ Medical Ventures 免费提供了 ExEm®-FOAM 试剂盒。资助者在研究设计、数据收集、分析或解释方面没有任何作用。HRV 报告了来自 Ferring 的咨询费。MWv 担任牛津大学出版社的副编辑，担任产科研究的独立方法学家，在该研究中他没有其他角色。MWv 是 Cochrane Fertility and Gynaecology 的协调编辑。BWJM 从 NHMRC（GNT1176437）获得了研究资助，并从 Merck KGaA 获得了研究资金。BWJM 报告说他在 Merck KGaA 担任观察性研究的顾问。VM 获得了 Guerbet、Merck 和 Ferring 的研究资助以及 Merck KGaA 的旅行和演讲费。其他作者没有利益冲突。
国际临床试验注册平台 NTR4746。
