The effect of prior hysterosalpingo-foam sonography or hysterosalpingography on tubal patency: a secondary analysis of a randomized controlled trial.

IF 6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY
Danah Kamphuis, Nienke van Welie, Joukje van Rijswijk, Marcel H A van Hooff, Jan-Peter de Bruin, Harold R Verhoeve, Femke Mol, Wilhelmina M van Baal, Cornelis B Lambalk, Jaap Stoker, Madelon van Wely, Patrick M M Bossuyt, Ben Willem J Mol, Kim Dreyer, Velja Mijatovic
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引用次数: 0

Abstract

Study question: Does hysterosalpingo-foam sonography (HyFoSy) prior to hysterosalpingography (HSG) or HSG prior to HyFoSy affect visible tubal patency when compared HSG or HyFoSy alone?

Summary answer: 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.

What is known already: 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).

Main results and the role of chance: 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.

Wider implications of the findings: 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.

Trial registration number: International Clinical Trials Registry Platform No. NTR4746.

先行子宫输卵管造影或子宫输卵管造影对输卵管通畅性的影响:随机对照试验的二次分析。
研究问题:在子宫输卵管造影(HSG)前进行子宫输卵管超声造影(HyFoSy)或在HyFoSy前进行HSG与单独进行HSG或HyFoSy相比,是否会影响可见输卵管通畅性?在使用替代方法进行输卵管通畅性检测之前接受 HyFoSy 或 HSG 与单独接受 HyFoSy 或 HSG 相比,在可见输卵管通畅性方面没有明显差异:HyFoSy和HSG是两种常用的可视输卵管通畅性检测方法,在评估输卵管通畅性方面具有较高的诊断准确性。这些检查还可提高生育能力,但其潜在机制仍未完全明了。研究设计、规模、持续时间:这项研究是随机对照 FOAM 研究的二次分析,在这项研究中,妇女通过 HyFoSy 和 HSG 接受输卵管通畅性检测,并根据手术顺序随机进行。参与者要么先进行 HyFoSy,然后进行 HSG,要么相反。在此,我们评估了在采用另一种输卵管通畅性检测方法之前先采用 HyFoSy 或 HSG 进行输卵管通畅性检测对可见输卵管通畅性的相对效果,并与单独采用这两种方法进行比较:年龄在 18 至 41 岁之间、计划接受输卵管通畅性检测的不孕妇女均有资格参与 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除外。为了评估 HyFoSy 对输卵管通畅性的影响,我们以 HSG 结果为依据,比较了在 HSG 之前接受和未接受 HyFoSy 的妇女中双侧输卵管通畅的比例(HSG 之前接受 HyFoSy 与仅接受 HSG 相比)。为了评估HSG对输卵管通畅性的影响,我们以HyFoSy结果为依据,比较了在HyFoSy前接受和未接受HSG的女性中,HyFoSy检查可见双侧输卵管通畅的比例(HyFoSy前接受HSG与单纯HyFoSy):2015年5月至2019年1月期间,我们随机抽取了1160名女性(576名先接受HyFoSy,再接受HSG;584名先接受HSG,再接受HyFoSy)。在随机接受先 HyFoSy 后 HSG 的女性中,467/537(87%)名女性的 HSG 结果显示双侧输卵管通畅,而仅接受 HSG 的女性为 472/544(87%)名(风险差异为 0.2%;95% CI:-3.8% 至 4.2%)。在HyFoSy前随机接受HSG检查的妇女中,394/471(84%)名妇女在HyFoSy时可见双侧输卵管通畅,而单独接受HyFoSy的妇女为428/486(88%)名(风险差异为-4.4%;95% CI:-8.8%至0.0%):该二次分析的结果应被解释为探索性的,不能被视为决定性的证据。此外,必须指出的是,本分析未考虑妊娠结果:与单独采用其他方法相比,在采用其他输卵管通畅性检测方法之前先采用 HyFoSy 或 HSG 进行输卵管通畅性检测,对可见输卵管通畅性的影响不大。这表明这两种方法清除输卵管粘液栓的能力相当:FOAM研究是一项由研究者发起的研究,由荷兰卫生研究与发展组织ZonMw资助(项目编号837001504)。IQ Medical Ventures 免费提供 ExEm®-FOAM 套件。资助方不参与研究设计、数据收集、分析或解释。H.R.V.从Ferring公司领取顾问费。M.v.W. 作为《人类生殖》的副主编,获得了牛津大学出版社的差旅费资助,并作为产科研究的独立方法论专家参加了数据安全和监测委员会,她在该委员会中没有其他职务。M.v.W. 是 Cochrane Fertility and Gynaecology 的协调编辑。B.W.J.M.获得了NHMRC(GNT1176437)的研究者基金和Merck KGaA的研究基金。B.W.J.M.报告为Organon和Merck KGaA的顾问,并获得Merck KGaA的差旅费资助。B.W.J.M. 报告持有 ObsEva 公司股票。V.M.获得了加柏公司、默克公司和Ferring公司的研究资助以及加柏公司的差旅费和演讲费。其他作者未报告利益冲突。试验注册号:国际临床试验注册平台NTR4746号。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Human reproduction
Human reproduction 医学-妇产科学
CiteScore
10.90
自引率
6.60%
发文量
1369
审稿时长
1 months
期刊介绍: Human Reproduction features full-length, peer-reviewed papers reporting original research, concise clinical case reports, as well as opinions and debates on topical issues. Papers published cover the clinical science and medical aspects of reproductive physiology, pathology and endocrinology; including andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, early pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues.
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