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

BACKGROUND. Ovarian cystectomy is the standard treatment of 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. OBJECTIVE. The purpose of this study was 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. METHODS. This prospective pilot study enrolled women evaluated for unilateral unilocular endometrioma measuring greater than 3 cm from March 2021 to July 2024. Participants were randomized to treatment by fluoroscopically guided and ultrasound-guided CDS or laparoscopic cystectomy. The primary endpoint was percentage decline from baseline to 12 months after intervention in serum antimüllerian hormone (AMH) level (an ovarian functional reserve marker). Additional procedural and 12-month outcomes, including the Endometriosis Health Profile-30 (EHP-30) questionnaire addressing endometriosis-related symptoms and quality of life (lower score: better status), were assessed. RESULTS. The analysis included 40 participants: 20 randomized to CDS (mean age, 32.8 years) and 20 to cystectomy (mean age, 35.1 years). The mean 12-month percentage decline in AMH level (primary outcome) was smaller for CDS than cystectomy (14.9% vs 39.8%, respectively; p = .02). No complications occurred after CDS; one complication occurred after cystectomy. Hospital length of stay was significantly shorter after CDS (mean ± SD, 2.3 ± 0.5 days) than after cystectomy (4.2 ± 0.7 days) (p < .001). From baseline to 12 months, ultrasound-based cyst size significantly decreased for CDS (mean ± SD: from 5.8 ± 1.5 to 0.6 ± 0.7 cm; p < .001) and for cystectomy (from 5.3 ± 1.4 to 0.0 ± 0.0 cm; p < .001); mean AMH level was not significantly different for CDS (from 3.1 ± 2.2 [SD] to 2.7 ± 1.7 ng/mL; p = .08) but decreased significantly for cystectomy (from 3.3 ± 3.0 to 2.0 ± 1.8 ng/mL; p < .001); mean CA-125 level decreased significantly for CDS (from 69.2 ± 61.7 [SD] to 17.3 ± 14.2 U/mL; p < .001) and cystectomy (from 54.6 ± 35.8 to 14.8 ± 8.2 U/mL; p < .001); and mean EHP-30 score decreased significantly for CDS (from 31.3 ± 12.8 [SD] to 6.3 ± 6.9; p < .001) and cystectomy (from 34.5 ± 18.0 to 8.1 ± 4.3; p .05). No 12-month recurrence occurred in either group. CONCLUSION. CDS was associated with better preservation of ovarian reserve versus cystectomy, without a significant difference in the therapeutic efficacy measures. CLINICAL IMPACT. These results advance the level of evidence supporting CDS as an ovary-sparing cystectomy alternative for appropriately selected patients. TRIAL REGISTRATION. ClinicalTrials.gov NCT05279209.