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Laparoscopic Sclerotherapy for the Management of Ovarian Endometriomas

NCT07481617 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-04-29

No results posted yet for this study

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. 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.

Conditions

  • Endometriosis
  • Endometrioma
  • Sclerotherapy
  • Laparoscopy

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.

Sponsors & Collaborators

Principal Investigators

  • Magdy Milad, MD · Northwestern University

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-16
Primary Completion
2027-07-31
Completion
2027-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07481617 on ClinicalTrials.gov