ATOPE study protocol: a randomised controlled trial comparing cystectomy and plasma vapourisation in endometriomas under 6 cm, with an observational arm for sclerotherapy in larger cysts.

INTRODUCTION

The Ablative Technique Options for Preserving fertility in Endometrioma study is a prospective, monocentric clinical study that combines a randomised controlled trial comparing cystectomy and plasma vapourisation for endometriomas measuring between 2 cm and 6 cm with a parallel observational cohort evaluating sclerotherapy for endometriomas larger than 6 cm. The primary outcome is the cumulative pregnancy rate at 24 months. Secondary outcomes include ovarian reserve, recurrence, complications and pain scores.

METHODS AND ANALYSIS: A total of 332 women with unilateral or bilateral ovarian endometriomas will be enrolled at Institut Franco-Européen de prise en charge multidisciplinaire de l'endométriose. Women with an indication for deep endometriosis surgery and endometriomas <6 cm will be randomised to receive either laparoscopic cystectomy or plasma vapourisation. Women with endometriomas >6 cm will be allocated to a prospective observational cohort undergoing laparoscopic sclerotherapy. The primary endpoint will be the cumulative pregnancy rate (spontaneous or assisted) at 24 months. Secondary outcomes include live birth rates, spontaneous and assisted reproductive technology pregnancy rates, rate of ongoing pregnancies beyond 12 weeks' gestational age, recurrence rates and postoperative complications. Intention-to-treat and per-protocol analyses will be performed.

ETHICS AND DISSEMINATION: Approved by the Comité de protection des personnes Île-de-France II, the study adheres to Standard Protocol Items: Recommendations for Interventional Trials and Consolidated Standards of Reporting Trials guidelines. Outcomes will be disseminated through peer-reviewed publications and international congresses.

TRIAL REGISTRATION NUMBER: NCT07119060.