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Endometrioma Sclerotherapy and Ovarian Preservation

Sponsor: Chelsea and Westminster NHS Foundation Trust

NCT ID: NCT06775769

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sclerotherapy (procedure), Routine Care (procedure)
How long the study runs
Study runs about 34 months (dates as stated)
About the drug or intervention
Sclerotherapy — procedure: Laparoscopic ethanol sclerotherapy of endometrioma · Routine Care — procedure: Routine surgical management of endometrioma
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 45 Years
Who
Female
Number of participants
60
Started
2025-02-21
Last checked
2025-11

Plain English Summary

What is this study?

  • • Testing a new treatment for endometrioma
  • • NA - 60 participants
  • • A randomised controlled trial assessing ovarian reserve after laparoscopic ethanol sclerotherapy of ovarian endometrioma compared to standard treatment of surgical excision of endometrioma

Who can take part?

  • • Ages 18 Years to 45 Years
  • • Diagnosed with endometrioma
  • • Female only

Where?

  • • London - Chelsea and Westminster NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Endometrioma

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 45 Years
  • Who can join: Female only

What the study is looking for

  • ✓Female (XX genotype, assigned female at birth)
  • ✓Age 18-40

Who cannot take part

  • ✗Postmenopausal status
  • ✗Suspicion of cancer
  • ✗Unable to undergo TVUSS
  • ✗Declines to take part in the study
  • ✗Unable to understand verbal or written information in English
See the full 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

Where Is This Study? (1 UK site)

Chelsea and Westminster NHS Foundation Trust

London SW10 9NH, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Sarah Bennet, BSc MBBS MRCOG

Sponsor contact

CONTACT

07983980924 sarah.bennet25@imperial.ac.uk

Thomas Bainton, BM BCh MRCOG MA(Oxon)

Sponsor contact

CONTACT

tombainton@doctors.org.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-11