O-249 Surgery versus IVF for the treatment of infertility associated to ovarian and deep endometriosis (SVIDOE). Preliminary results from a multicenter randomized controlled trial

Study question Is IVF more effective than surgery for treating infertility associated to ovarian and deep endometriosis detected at ultrasound? Summary answer The live birth rate within a year from the study’s beginning was significantly higher in IVF group compared to that obtained in the surgery group What is known already The management of endometriosis-associated infertility is still controversial. To date, no randomized controlled trials (RCTs) have definitively clarified the potential benefits of surgery versus assisted reproductive techniques in women with advanced endometriosis, particularly those with ovarian endometriomas or deep peritoneal lesions. Currently, the choice between surgery and IVF is individualized, considering the advantages and limitations of each approach alongside the patient’s clinical profile. Due to the absence of RCTs or robust prospective studies, treatment strategies for women with endometriosis vary significantly across centers. Study design, size, duration This is a multicentric, not blinded, RCT comparing pregnancy chances between infertile women with sonographically identified endometriosis undergoing surgery and those treated with IVF. All participants underwent infertility treatments or surgery at Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, IRCCS San Raffaele Scientific Institute or Macedonio Melloni Hospital (Milan-Italy), between April 2021 and September 2024. Participants/materials, setting, methods Endometriosis women who had been seeking pregnancy for over 12 months with a partner with normal semen were randomized to either surgery followed by natural pregnancy attempts or a three-cycle IVF program. Women who declined randomization were monitored in a patient-preference trial (PPT). Previous surgery for endometriosis was an exclusion criterion. The primary outcome included only live births achieved within 12 months from the study’s starting point. Main results and the role of chance A total of 130 women were recruited. Among them, 55 were randomized (28 to IVF and 27 to surgery), while 75 chose their preferred treatment (50 opted for IVF and 25 for surgery). Baseline characteristics were comparable between the two groups. In the intention-to-treat analysis, the live birth rate (LBR) was significantly higher in the IVF group compared to the surgery group (46% vs. 23%, p = 0.009). Additionally, 12 pregnancies are still ongoing, with an ongoing pregnancy rate (>20 weeks) of 60% in the IVF group and 27% in the surgery group (p < 0.001). Kaplan-Meier survival analysis of time to LBR further demonstrated a significant advantage for IVF (p = 0.004). Six patients conceived naturally before treatment, and six withdrew from the trial, leading to a per-protocol analysis including 118 patients. The results remained consistent, with LBR still significantly higher in the IVF group compared to surgery (47% vs. 20%, p = 0.005). The ongoing pregnancy rate was also significantly greater in the IVF group (60% vs. 24%, p < 0.001). Results were similar when exclusively focussing on randomized subjects. Limitations, reasons for caution A key limitation is the inclusion of patients who selected their treatment rather than being randomly assigned, as 57% declined randomization, introducing potential selection bias. However, baseline characteristics were similar, and the distribution between the two groups remained balanced, helping to mitigate this bias. Wider implications of the findings This is the first RCT comparing surgery and IVF for endometriosis-related infertility. The significantly higher likelihood of achieving a live birth with IVF is expected to influence counselling for infertile women with endometriosis, offering clearer guidance on treatment choices. Trial registration number Yes