EFFORT study: Comparison of the impact of surgery and assisted reproductive technologies on fertility in women with deep infiltrating endometriosis – study protocol for a multicenter randomized trial

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BMJ open. 2022 Apr 11;12(4):e052877. doi: 10.1136/bmjopen-2021-052877.

ABSTRACT

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

METHODS AND ANALYSIS: Multicenter, parallel-group, randomized trial of women with rectosigmoid DIE and pregnancy intention of at least 6 months in Aarhus, Denmark and Bordeaux, France. 352 women aged 18-38 are randomized 1:1 for surgical management (shaving, disc excision or segmental resection) or ART management (at least two in vitro fertilization or intracytoplasmic sperm injection procedures if they are not pregnant after the first cycle). Women in the surgery group will attempt to become pregnant either by spontaneous conception or ART, depending on the Endometriosis Fertility Index score. The primary endpoints are CPR and LBR at 18 months follow-up. The secondary endpoints 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 of either procedure.

ETHICS AND DISSEMINATION: The conduct of this study is approved by the Danish National Health Research Ethics Committee and the Ile de France VIII People’s Protection Committee. Study participants must sign an informed consent form. The results will be presented at national and international conferences and published in peer-reviewed international journals.

TRIAL REGISTRATION NUMBER: This trial is registered with ClinicalTrials.gov (#NCT04610710).

PROTOCOL VERSION: Danish National Health Research Ethics Committee: fifth version of the protocol approved on September 7, 2020 (no. 1-10-72-96-20). Committee for the Protection of Persons Ile de France VIII: Version 1.1 22JAN2021 March 9, 2021.

PMID:35410921 | DOI:10.1136/bmjopen-2021-052877

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