Catheter-Directed Sclerotherapy Versus Ovarian Cystectomy for Unilateral Ovarian Endometrioma: A Pilot Randomized Controlled Trial.

Abstract

<b>Background:</b> Ovarian cystectomy is standard treatment for endometrioma but is associated with decreased ovarian reserve. Catheter-directed sclerotherapy (CDS) is an ovary-sparing image-guided alternative; however, supporting evidence comprises retrospective comparative and prospective single-arm studies. <b>Objective:</b> To compare CDS and ovarian cystectomy in terms of therapeutic efficacy and effect on ovarian function in women with ovarian endometrioma through a randomized controlled trial. <b>Methods:</b> This prospective pilot study enrolled women evaluated for unilateral unilocular endometrioma measuring >3 cm from March 20221 to July 2024. Participants were randomized to treatment by fluoroscopic and ultrasound-guided CDS or laparoscopic cystectomy. The primary endpoint was percentage decline from baseline to 12 months in serum anti-Müllerian hormone (AMH) (an ovarian functional reserve marker). Additional procedural and 12-month outcomes were assessed including the Endometriosis Health Profile-30 (EHP-30) questionnaire addressing endometriosis-related symptoms and quality of life (lower score: better status). <b>Results:</b> The analysis included 40 participants: 20 randomized to CDS (mean age, 32.8 years), and 20 (mean age, 35.1.1 years) to cystectomy. Mean 12-month percentage decline in AMH (primary outcome) was smaller for CDS than cystectomy (14.9% vs 39.8%, P=.02). No complications occurred after CDS; one complication occurred after cystectomy. Hospital length of study was significantly shorter after CDS (2.3±0.5 days) than cystectomy (4.2±0.7 days) (P<.001). From baseline to 12 months, ultrasound-based cyst size significantly decreased for CDS (5.8±1.5 to 0.6±0.7 cm; P<.001) and cystectomy (5.3±1.4 to 0.0±0.0 cm; P<.001); mean AMH was not significantly different for CDS (3.1±2.2 to 2.7±1.7 ng/mL; P=.08) but decreased significantly for cystectomy (3.3±3.0 to 2.0±1.8 ng/mL; P<.001); mean CA-125 decreased significantly for CDS (69.2±61.7 to 17.3±14.2 U/mL; P<.001) and cystectomy (54.6±35.8 to 14.8±8.2 U/mL; P<.001); and mean EHP-30 score decreased significantly for CDS (31.3±12.8 to 6.3±6.9; P<.001) and cystectomy (34.5±18.0 to 8.1±4.3; P<.001). CA-125 and EHP-30 score were not significantly different between groups at 12 months (P>.05). No 12-month recurrence occurred in either group. <b>Conclusion:</b> CDS was associated with better preservation of ovarian reserve versus cystectomy, without significant difference for therapeutic efficacy measures. <b>Clinical Impact:</b> These results advance the level of evidence supporting CDS as an ovary-sparing cystectomy alternative for appropriately selected patients.