RecruitingNot ApplicableNCT06775769

Endometrioma Sclerotherapy and Ovarian Preservation

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


Sponsor

Chelsea and Westminster NHS Foundation Trust

Enrollment

60 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

PROCEDURESclerotherapy

Laparoscopic ethanol sclerotherapy of endometrioma

PROCEDURERoutine Care

Routine surgical management of endometrioma


Locations(1)

Chelsea and Westminster NHS Foundation Trust

London, United Kingdom

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NCT06775769


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