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NOT YET RECRUITING
NCT07481617

Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas

Sponsor: Northwestern University

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the effect of laparoscopic sclerotherapy on ovarian reserve and its overall efficacy in the treatment of endometriomas. Ovarian reserve will be assessed using preoperative and postoperative anti-Müllerian hormone (AMH) levels and antral follicle count (AFC). Traditionally, ovarian endometriomas are managed by complete cystectomy; however, multiple studies including a large systematic review and meta-analysis-have demonstrated that cystectomy significantly reduces ovarian reserve, with an average decline in AMH of 1.77 ng/mL within one to six weeks postoperatively without recovery to baseline after many months. Sclerotherapy has historically been a potential alternative, typically performed by interventional radiology via transvaginal, transabdominal, or transgluteal drainage. This percutaneous approach, however, precludes direct visualization of the cyst and surgical management of concurrent conditions including endometriosis peritoneal disease, excision, adhesions, or tubal disease. Several studies have explored the feasibility and effectiveness of laparoscopic sclerotherapy, reporting encouraging results regarding its safety, increased AFC compared with cystectomy, and comparable pregnancy rates. Nonetheless, none of these studies have been conducted in the United States, and few have utilized a laparoscopic approach. Further research is therefore warranted to establish the accessibility and reproducibility of this technique. We aim to conduct the first U.S.-based study evaluating the impact of laparoscopic sclerotherapy on ovarian reserve. The primary outcome will be the change in AMH and AFC at six weeks postoperatively. Consistent with prior evidence, we hypothesize that laparoscopic sclerotherapy will result in a smaller decline in ovarian reserve compared with traditional cystectomy.

Official title: Laparoscopic Sclerotherapy for Management of Endometriomas: A Pilot Study Evaluating Impact on Ovarian Reserve

Key Details

Gender

FEMALE

Age Range

18 Years - 55 Years

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2026-03-16

Completion Date

2027-08-30

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

PROCEDURE

Laparoscopic sclerotherapy

Standard of care for an endometrioma is a laparoscopic cystectomy. This procedure still uses laparoscopy however instead of a cystectomy, the ovarian cyst is drained and ethanol is instilled for sclerotherapy and then removed from the cyst. The benefit is hopefully a lesser impact on ovarian reserve as opposed to ovarian cystectomy.