Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Nov 24;14(11):e091778.
doi: 10.1136/bmjopen-2024-091778.

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)

Danah Kamphuis  1   2 , Janette P M Huijser  3   2 , Nienke van Welie  3   2 , Harold R Verhoeve  4 , Esther Kuijper  5 , Jan Peter de Bruin  6 , Angelique J C M van Dongen  7 , Susanne C J P Gielen  8 , Guusje de Krom  9 , Femi Janse  10 , Carolien A M Koks  11 , Annemiek W Nap  12 , Johannes R Anema  13 , Judith E Bosmans  14 , Jaap Stoker  15 , Madelon van Wely  2   16 , Ben Willem J Mol  17 , Velja Mijatovic  3   2 , Kim Dreyer  3   2
Affiliations

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)

Danah Kamphuis et al. BMJ Open. .

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.

Keywords: Pregnancy; Randomized Controlled Trial; Reproductive medicine; Subfertility.

PubMed Disclaimer

Conflict of interest statement

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.

References

    1. Thoma ME, McLain AC, Louis JF, et al. Prevalence of infertility in the United States as estimated by the current duration approach and a traditional constructed approach. Fertil Steril. 2013;99:1324–31. doi: 10.1016/j.fertnstert.2012.11.037. - DOI - PMC - PubMed
    1. Sun H, Gong T-T, Jiang Y-T, et al. Global, regional, and national prevalence and disability-adjusted life-years for infertility in 195 countries and territories, 1990–2017: results from a global burden of disease study, 2017. Aging (Milano) 2019;11:10952–91. doi: 10.18632/aging.102497. - DOI - PMC - PubMed
    1. Zegers-Hochschild F, Adamson GD, Dyer S, et al. The International Glossary on Infertility and Fertility Care, 2017. Hum Reprod. 2017;32:1786–801. doi: 10.1093/humrep/dex234. - DOI - PMC - PubMed
    1. Ata B, Bhattacharya S, Bosch E, et al. Evidence-based guideline: unexplained infertility.: eshre. 2023. https://www.eshre.eu/guideline/UI Available. - PMC - PubMed
    1. NICE National institute for health and care excellence. 2013. https://www.nice.org.uk/guidance/cg156 Available.

Publication types

Associated data