Endometrioma Sclerotherapy and Ovarian Preservation
Recruiting · NCT06775769 · Interventional (participants receive a specific treatment) · Lead sponsor: Chelsea and Westminster NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
Routine CareSclerotherapy
What this trial is about
A randomised controlled trial assessing ovarian reserve after laparoscopic ethanol sclerotherapy of ovarian endometrioma compared to standard treatment of surgical excision of endometrioma. Secondary outcomes will include endometrioma recurrence, symptomatology and inflammatory environment.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Chelsea and Westminster NHS Foundation Trust - London, United Kingdom