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RecruitingNCT06775769

Endometrioma Sclerotherapy and Ovarian Preservation

Endometrioma Sclerotherapy and Ovarian Preservation: a Randomised Control Trial of Laparoscopic Sclerotherapy vs Traditional Excision of Endometrioma

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Chelsea and Westminster NHS Foundation Trust · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESclerotherapyLaparoscopic ethanol sclerotherapy of endometrioma
PROCEDURERoutine CareRoutine surgical management of endometrioma

Timeline

Start date
2025-02-21
Primary completion
2027-12-31
Completion
2027-12-31
First posted
2025-01-15
Last updated
2025-11-25

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT06775769. Inclusion in this directory is not an endorsement.