Endometrioma Sclerotherapy and Ovarian Preservation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sclerotherapy, Routine Care.
- Who it may be relevant to
- Registry conditions: Endometrioma. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Endometrioma Sclerotherapy and Ovarian Preservation: a Randomised Control Trial of Laparoscopic Sclerotherapy vs Traditional Excision of Endometrioma
Overview
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.
Interventions
- Procedure Sclerotherapy
Laparoscopic ethanol sclerotherapy of endometrioma - Procedure Routine Care
Routine surgical management of endometrioma
Primary outcome measures
- Ovarian Reserve [Time frame: 24 months]
Secondary outcome measures (3)
- Endometrioma recurrence [Time frame: 24 monhts]
- Symptomatology [Time frame: 24 monhts]
- Inflammation [Time frame: 24 monhts]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Chelsea and Westminster NHS Foundation Trust — London
Identifiers
NCT: NCT06775769 · 24/LO/0825