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NCT Number: NCT06775769

Endometrioma Sclerotherapy and Ovarian Preservation

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chelsea and Westminster NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location status: Recruiting

Location contact

Gulsah Cetinkaya

CONTACT

[email protected]

020 3315 6646

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sclerotherapy

Procedure

Laparoscopic ethanol sclerotherapy of endometrioma

Routine Care

Procedure

Routine surgical management of endometrioma

Primary outcomes

  1. Ovarian Reserve

    Time frame: 24 months

    To determine the statistical difference in ovarian reserve pre- and post- treatment (as measured by serum AMH at 3, 6, 12 and 24 months and antral follicle count at 6, 12 and 24 months) in participants randomised to receive laparoscopic ethanol sclerotherapy or laparoscopic excision of endometrioma

Secondary outcomes

  1. Endometrioma recurrence

    Time frame: 24 monhts

    To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma alters recurrence of ovarian endometrioma (as measured by TVUSS at 6, 12 and 24 months) as compared to laparoscopic excision of endometrioma

  2. Symptomatology

    Time frame: 24 monhts

    To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma affects symptomatology (as recorded by EHP-30) as compared to laparoscopic excision of endometrioma at 3, 6, 12 and 24 months

  3. Inflammation

    Time frame: 24 monhts

    To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma alters the inflammatory environment (as measured in blood at 3, 6, 12 and 24 months, and endometrial biopsy at 6 months) as compared to laparoscopic excision of endometrioma

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Bennet, BSc MBBS MRCOG

CONTACT

[email protected]

07983980924

Thomas Bainton, BM BCh MRCOG MA(Oxon)

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Chelsea and Westminster NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: ENDOSAVE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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