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).

Autor:	Kamphuis D; Reproductive Medicine, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands d.kamphuis@amsterdamumc.nl.; Amsterdam Reproduction and Development Research Institute, Amsterdam, The Netherlands., Huijser JPM; Reproductive Medicine, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands.; Amsterdam Reproduction and Development Research Institute, Amsterdam, The Netherlands., van Welie N; Reproductive Medicine, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands.; Amsterdam Reproduction and Development Research Institute, Amsterdam, The Netherlands., Verhoeve HR; Obstetrics and Gynaecology, OLVG, Amsterdam, The Netherlands., Kuijper E; Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, The Netherlands., de Bruin JP; Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands., van Dongen AJCM; Obstetrics and Gynaecology, Gelderse Vallei Hospital, Ede, The Netherlands., Gielen SCJP; Obstetrics and Gynaecology, Franciscus Hospital, Rotterdam, The Netherlands., de Krom G; Obstetrics and Gynaecology, Zuyderland Medical Center, Heerlen, The Netherlands., Janse F; Obstetrics and Gynaecology, Rijnstate, Arnhem, The Netherlands., Koks CAM; Obstetrics and Gynaecology, Maxima Medical Center, Veldhoven, The Netherlands., Nap AW; Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands., Anema JR; Public and Occupational Health, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands., Bosmans JE; Department of Health Sciences, Faculty of Science, Amsterdam Public Health, research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands., Stoker J; Radiology and Nuclear Medicine, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands., van Wely M; Amsterdam Reproduction and Development Research Institute, Amsterdam, The Netherlands.; Centre for Reproductive Medicine, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands., Mol BWJ; Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia., Mijatovic V; Reproductive Medicine, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands.; Amsterdam Reproduction and Development Research Institute, Amsterdam, The Netherlands., Dreyer K; Reproductive Medicine, Amsterdam UMC location Vrije Universiteit, Amsterdam, The Netherlands.; Amsterdam Reproduction and Development Research Institute, Amsterdam, The Netherlands.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Nov 24; Vol. 14 (11), pp. e091778. Date of Electronic Publication: 2024 Nov 24.
DOI:	10.1136/bmjopen-2024-091778
Abstrakt:	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.)
Databáze:	MEDLINE
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