Impact of surgery on fertility among patients with deep infiltrating endometriosis.

OBJECTIVE: The aim of the study was to investigate pregnancy and live birth rate after surgical resection of rectosigmoid deep infiltrating endometriosis (DIE), and study if complications affect these rates. STUDY DESIGN: Historical case series. 193 patients with rectosigmoid DIE and pregnancy intention undergoing a rectosigmoid resection for DIE from January 2009 to May 2019. All operations were performed at the Department of Obstetrics and Gynecology, Aarhus University Hospital, Denmark. Surgical and fertility outcome data were obtained through patient files. Anonymized data was analyzed statistically. Normally distributed continuous variables are stated as means, categorical data as percentages and time to pregnancy as Kaplan-Meier failure function. Live birth rates stratified on complications were tested with chi2 test. RESULTS: 117 patients became pregnant postoperatively with a pregnancy and live birth rate of 60.6% and 53.9%, respectively. 39 patients (20.2%) became pregnant spontaneously and 78 patients (40.4%) by intrauterine insemination or assisted reproductive technologies. Median time to pregnancy after surgery was 12.4 months (range: 0.4-58). Clavien-Dindo complication grade III (none grade IV) was registered among 16.6%. These patients had pregnancy and live birth rates of 50%, not statistically significantly different from those without complications. CONCLUSIONS: Postoperative pregnancy and live birth rates after resection of rectosigmoid endometriosis in this study are in line with conservative treatment, when comparing with the literature. Interestingly, complications (Clavien-Dindo grade III) did not affect live birth rate or time to pregnancy.

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.

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.