EFFORT study: Comparing impact of operation and assisted reproductive technologies on fertility for women with deep infiltrating endometriosis - study protocol for a multicentre randomised trial

Maja Raos, Horace Roman, Mikkel Seyer-Hansen, Ulrik Schiøler Kesmodel, Ulla Breth Knudsen, Maja Raos, Horace Roman, Mikkel Seyer-Hansen, Ulrik Schiøler Kesmodel, Ulla Breth Knudsen

Abstract

Introduction: Deep infiltrating endometriosis (DIE) affecting the rectum or sigmoid colon is associated with infertility, severe pain and decreased quality of life. As most women with DIE are young, many have a pregnancy intention. Treatment possibilities of endometriosis-associated infertility are surgery or assisted reproductive technologies (ART). However, no studies have compared the two interventions directly. Therefore, this study aims to determine the cumulative pregnancy rate (CPR) and the live birth rate (LBR) after first-line surgery compared with first-line ART for women with rectosigmoid DIE and a pregnancy intention.

Methods and analysis: Multicentre, parallel-group, randomised trial of women with rectosigmoid DIE and a pregnancy intention for at least 6 months in Aarhus, Denmark and Bordeaux, France. 352 women aged 18-38 years are randomised 1:1 to either surgical management (shaving, disc excision or segmental resection) or ART management (at least two in vitro fertilisation or intracytoplasmic sperm injection procedures if not pregnant after the first cycle). Women in the surgical intervention group will attempt to get pregnant by either spontaneous conception or ART, depending on the endometriosis fertility index score. Primary outcome measures are CPR and LBR at 18 months' follow-up. Secondary outcomes are: Non-viable pregnancies, time to pregnancy, pain score, quality of life, complication rate, bowel and bladder function, endocrine and inflammatory profile, number of oocytes, blastocysts, frozen embryos and blastocyst morphology score within 18 months after either intervention.

Ethics and dissemination: Conduct of this study is approved by the Danish National Committee on Health Research Ethics and Comité de Protection des Personnes Ile de France VIII. Study participants must sign an informed consent form. The results will be presented at national and international conferences and published in international peer-reviewed journals.

Trial registration number: This trial is registered at ClinicalTrials.gov (no. NCT04610710).

Protocol version: The Danish National Committee on Health Research Ethics: Fifth protocol version approved 7 September 2020 (no. 1-10-72-96-20). Comité de Protection des Personnes Ile de France VIII: Version 1.1 22JAN2021 the 9 March 2021.

Keywords: Minimally invasive surgery; Reproductive medicine; Subfertility.

Conflict of interest statement

Competing interests: UBK has received institutional funding targeted for this study by IBSA Nordic, and institutional funding by Ferring Pharmaceuticals and Merck A/S for departmental research activity. HR has received consultant fees for training involvement by Olympus, Karl Storz, PlasmaSurgical and Ethicon.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study time plan and follow-up study points for primary and secondary outcomes data acquisition. DIE, deep infiltrating endometriosis; EFI, Endometriosis Fertility Index; IVF, in vitro fertilisation.

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