Clinical trial NCT06775769: Endometrioma Sclerotherapy and Ovarian Preservation
Official title: Endometrioma Sclerotherapy and Ovarian Preservation: a Randomised Control Trial of Laparoscopic Sclerotherapy vs Traditional Excision of Endometrioma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrioma
Keywords: Endometrioma
Endometriosis
Sclerotherapy
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised control trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Participants with endometrioma(ta), identified on imaging, who are opting for surgical management of endometriosis will be randomly allocated to laparoscopic ethanol sclerotherapy of endometrioma or laparoscopic surgical excision of endometrioma(ta). Any concurrent endometriosis identified at surgery will be excised as per routine care.

Ovarian reserve will be assessed by serum anti-Mullarian hormone (AMH) and antral follicle count (AFC), recurrence will me assessed by transvaginal ultrasound, symptomatology will be assessed by EHP-30 questionnaires and changes in inflammation assessed in serum and endometrial biopsy.

Each participant will be followed up for a total of 24 months from surgery.

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

Primary outcomes:
measure: Ovarian Reserve
timeFrame: 24 months
Secondary outcomes:
measure: Endometrioma recurrence
timeFrame: 24 monhts
measure: Symptomatology
timeFrame: 24 monhts
measure: Inflammation
timeFrame: 24 monhts
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster NHS Foundation Trust
Study officials:
References: