Endometrioma Sclerotherapy and Ovarian Preservation

Sponsored by Chelsea and Westminster NHS Foundation Trust

About this trial

Last updated 5 months ago

Study ID

24/LO/0825

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 45 Years

Female

Trial Timing

Started a year ago

What is this trial 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.

What are the participation requirements?

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