Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-02-21
2027-12-31
Brief Summary
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Secondary outcomes will include endometrioma recurrence, symptomatology and inflammatory environment.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Surgical Management of Endometrioma
Routine Care
Routine Care
Routine surgical management of endometrioma
Laparoscopic Sclerotherapy
Laparoscopic ethanol sclerotherapy of endometrioma
Sclerotherapy
Laparoscopic ethanol sclerotherapy of endometrioma
Interventions
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Sclerotherapy
Laparoscopic ethanol sclerotherapy of endometrioma
Routine Care
Routine surgical management of endometrioma
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Chelsea and Westminster NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Chelsea and Westminster NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24/LO/0825
Identifier Type: -
Identifier Source: org_study_id
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