Endometrioma Sclerotherapy and Ovarian Preservation

Last updated: April 17, 2025
Sponsor: Chelsea and Westminster NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Treatment

Routine Care

Sclerotherapy

Clinical Study ID

NCT06775769
24/LO/0825
  • Ages 18-40
  • Female

Study 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 Criteria

Inclusion

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 TVUSSand/or pelvic MRI scan (TVUSS, a uni- or multi-locular ovarian cystic lesion withlow 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 restricteddiffusion on DWI)

  • Appropriate to be listed for laparoscopic excision of endometrioma (Endometrioma ≥2cm, pain symptoms attributable to endometriosis where medical management isunsuccessful or unacceptable to the patient, to facilitate ART)

Exclusion

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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Routine Care
Phase:
Study Start date:
February 21, 2025
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Chelsea and Westminster NHS Foundation Trust

    London, SW10 9NH
    United Kingdom

    Active - Recruiting

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