Endometrioma Sclerotherapy and Ovarian Preservation

Launched by CHELSEA AND WESTMINSTER NHS FOUNDATION TRUST · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for women with endometriomas, which are cysts formed on the ovaries due to endometriosis. The trial aims to compare two methods: one is laparoscopic ethanol sclerotherapy, a less invasive procedure that involves injecting alcohol into the cyst, and the other is standard surgical excision, which means removing the cyst. Researchers want to see how these treatments affect women's ovarian reserve, or their ability to produce eggs, along with looking at how often the endometriomas come back and how they affect symptoms.

To be eligible for this trial, participants must be women aged 18 to 40 who have been diagnosed with one or more endometriomas that are at least 2 cm in size. They should be experiencing pain from their condition and have not found relief through other treatments. Participants will receive one of the two treatments and be monitored for their ovarian health and any changes in their symptoms. If you're interested in joining the study, it's important to know that it’s currently recruiting, and the trial specifically excludes women who are postmenopausal or have concerns about cancer.

Gender

FEMALE

Eligibility 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