EFFORT study: Surgery vs assisted reproductive technology among women with deep endometriosis – A multicenter randomized controlled trial

OBJECTIVE: To compare surgery and assisted reproductive technology (ART) treatment on reproductive outcomes among women with rectosigmoid endometriosis. DESIGN: Multicenter, parallel-group, non-blinded, randomized controlled trial. SETTING: Women were enrolled from November 2020 to December 2023 at two tertiary endometriosis referral centers, either at the Department of Obstetrics and Gynecology in Aarhus, Denmark, or at IFEM Endo at Clinique Tivoli Ducos in Bordeaux, France. PARTICIPANTS: Inclusion criteria were age between 18-38, diagnosis of rectosigmoid endometriosis, pregnancy intention of at least six months, a male partner, an acceptable anti-Müllerian hormone level (>5 pmol/L), and no more than two previous ART cycles. INTERVENTIONS: The women were randomly allocated to either surgery or ART with follow-up at nine and 18 months. RESULTS: 38 women were enrolled, 20 of whom were allocated to the ART group and 18 to the surgery group. After surgery, 61.1% (11/18) of the women became pregnant, of which 45.5% (5/11) occurred spontaneously. In parallel, 80.0% (16/20) became pregnant after ART with 31.3% (5/16) as spontaneous conceptions. Seven (38.9%) of the pregnancies resulted in live birth after surgery, and 13 (65.0%) after ART. No difference in these primary outcomes was observed between surgery and ART as treatment for endometriosis-associated infertility. CONCLUSION: No significant difference in reproductive outcomes was revealed between surgery and ART among women with rectosigmoid endometriosis. However, the study population was small and underpowered, meaning the findings are uncertain and conclusions difficult to draw. The trial was registered at ClinicalTrials.gov (no. NCT04610710).