Treatment options for ovarian endometrioma
Endometrioma Sclerotherapy and Ovarian Preservation: a Randomised Control Trial of Laparoscopic Sclerotherapy vs Traditional Excision of Endometrioma
This study is testing whether a new method using ethanol can treat ovarian endometriomas as well as or better than standard surgery, while also looking at how it affects women's fertility and symptoms over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Chelsea and Westminster NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06775769 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of laparoscopic ethanol sclerotherapy compared to standard surgical excision for treating ovarian endometriomas. Participants will be randomly assigned to one of the two treatment groups, and their ovarian reserve will be assessed through serum anti-Müllerian hormone levels and antral follicle counts. Secondary outcomes include monitoring for endometrioma recurrence, symptom relief, and changes in inflammation over a follow-up period of 24 months. The study aims to provide insights into preserving ovarian function while managing endometriomas.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-40 with suspected ovarian endometriomas of 2cm or larger who are seeking surgical management for endometriosis.
Not a fit: Patients who are postmenopausal or have suspected malignancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive treatment option that preserves ovarian function for women with endometriomas.
How similar studies have performed: Previous studies have shown promise in using sclerotherapy for endometriomas, but this specific approach is being evaluated for its effectiveness in preserving ovarian reserve.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female (XX genotype, assigned female at birth) * Age 18-40 * Finding of suspected uni- or bi-lateral ovarian endometrioma(ta) of ≥ 2cm on TVUSS and/or pelvic MRI scan (TVUSS, a uni- or multi-locular ovarian cystic lesion with low level echoes and diffuse homogeneous ground glass appearance; MRI any of, ovarian lesion hyperintense T1 without loss of signal on T1 fat-suppressed images, hypointense T2 exhibiting shading sign and/or T2 dark spot sign, variable restricted diffusion on DWI) * Appropriate to be listed for laparoscopic excision of endometrioma (Endometrioma ≥2cm, pain symptoms attributable to endometriosis where medical management is unsuccessful or unacceptable to the patient, to facilitate ART) Exclusion Criteria: * Postmenopausal status * Suspicion of malignancy * Unable to undergo TVUSS * Declines to take part in the study * Unable to understand verbal or written information in English * Lack of capacity to consent at the point of recruitment * Known safeguarding issues
Where this trial is running
London
- Chelsea and Westminster NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Sarah Bennet, BSc MBBS MRCOG
- Email: sarah.bennet25@imperial.ac.uk
- Phone: 07983980924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.