1. Tubal flushing with oil-based contrast during hysterosalpingography versus tubal flushing by hysterosalpingo-foam sonography in infertile women undergoing fertility work-up: study protocol of a randomised controlled trial (FOil study).
- Author
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Kamphuis D, Huijser JPM, van Welie N, Verhoeve HR, Kuijper E, de Bruin JP, van Dongen AJCM, Gielen SCJP, de Krom G, Janse F, Koks CAM, Nap AW, Anema JR, Bosmans JE, Stoker J, van Wely M, Mol BWJ, Mijatovic V, and Dreyer K
- Subjects
- Humans, Female, Pregnancy, Adult, Pregnancy Rate, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Hysterosalpingography methods, Contrast Media administration & dosage, Infertility, Female diagnostic imaging, Infertility, Female therapy, Fallopian Tube Patency Tests methods, Ultrasonography methods, Fallopian Tubes diagnostic imaging
- Abstract
Introduction: Hysterosalpingography (HSG) and hysterosalpingo-foam sonography (HyFoSy) are commonly used tubal patency tests during the fertility work-up. Besides its diagnostic purpose, HSG with oil-based contrast can also be applied for its fertility-enhancing effect, by tubal flushing. HyFoSy is considered as less painful compared with HSG, it lacks exposure to iodinated contrast medium and ionising radiation. The fertility-enhancing effects of HyFoSy are less studied and randomised controlled trials comparing pregnancy rates after HSG and HyFoSy are lacking. This study (FOil study) is initiated to compare the effectiveness of tubal flushing during HSG with oil-based contrast and HyFoSy., Methods and Analysis: The FOil study is a nationwide, multicentre, open label, randomised controlled trial with a superiority design. Infertile women with an indication for tubal patency testing during their fertility work-up will be randomly assigned to HSG with oil-based contrast medium or HyFoSy. The primary outcome is conception within 6 months after randomisation leading to live birth. To demonstrate or refute an 8% difference in conception leading to live birth in favour of HSG with oil-based contrast, 1102 women will be included in the trial. A cost-effectiveness analysis from a societal perspective will be performed alongside the trial., Ethics and Dissemination: The trial is approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers (Ref. No. 2022.0884, date: 17 March 2023) and by the boards of the participating hospitals. The findings will be disseminated in peer-reviewed journals and participants will be informed through the patient organisation., Trial Registration Number: NCT05882188., Competing Interests: Competing interests: DK reports support from Guerbet. MvW is coordinating editor of the Cochrane Gynaecology and Fertility Group and member of the Cochrane thematic group Reproductive Health. HV is a member of the advisory board of Ferring Ltd, member of the ESHRE unexplained infertility guideline development group, and chairman of the Dutch unexplained infertility guideline development group. FJ is director of the Dutch Menopause Society. BWM received an investigator grant from NHMRC (GNT1176437), and research funding from Merck KGaA. BWM reports consulting fees from Merck KGaA, Organon, and Norgine and travel support from Merck KGaA. BWM reports holding stocks from ObsEva. VM, his department, received research grants from Guerbet, Merck and Ferring and travel and speakers fee from Guerbet. The other authors do not report conflicts of interest. KD, her department, received research grants from ZonMw and Guerbet outside the submitted work., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2024
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