Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas

Sponsor
Northwestern University
Study ID
NCT07481617
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Laparoscopic sclerotherapy — PROCEDURE
    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.

Study Details

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. The investigators 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, the investigators hypothesize that laparoscopic sclerotherapy will result in a smaller decline in ovarian reserve compared with traditional cystectomy.

Key Dates

First listed
Mar 19, 2026
Start date
May 16, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Laparoscopic Sclerotherapy
    Patients who choose to undergo laparoscopic sclerotherapy for management of their ovarian endometrioma.

Primary Outcome Measure

AMH [ Time Frame: 6 weeks ]

Central Contacts

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