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RecruitingNCT06775769ENDOSAVEUpdated Nov 25, 2025

Endometrioma Sclerotherapy and Ovarian Preservation

An interventional study of Sclerotherapy and Routine Care in Endometrioma, sponsored by Chelsea and Westminster NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Chelsea and Westminster NHS Foundation Trust · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

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.

Read the detailed 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.

02

Conditions studied

  • Endometrioma

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Keywords

  • Endometrioma
  • Endometriosis
  • Sclerotherapy
03

In context

Endometriosis

920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.

This study's planned enrollment of 60 is below the median of 67 across 540 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 54 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • status
  • Suspicion of
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Other
    Surgical Management of Endometrioma

    Routine Care

    Procedure: Routine Care

  • Experimental
    Laparoscopic Sclerotherapy

    Laparoscopic ethanol sclerotherapy of endometrioma

    Procedure: Sclerotherapy

Interventions

  • ProcedureSclerotherapy

    Laparoscopic ethanol sclerotherapy of endometrioma

  • ProcedureRoutine Care

    Routine surgical management of endometrioma

06

What researchers measure

Primary outcomes

  1. Ovarian Reserve

    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

    Time frame: 24 months

Secondary outcomes

  1. Endometrioma recurrence

    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

    Time frame: 24 monhts

  2. Symptomatology

    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

    Time frame: 24 monhts

  3. Inflammation

    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

    Time frame: 24 monhts

07

Study locations

1 of 1 sites recruiting
  • Chelsea and Westminster NHS Foundation Trust
    London, SW10 9NH, United Kingdom
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06775769
Lead sponsor
Chelsea and Westminster NHS Foundation Trust
Responsible party
Sponsor
First posted
Jan 15, 2025
Start date
Feb 21, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 25, 2025

Study contacts

Sarah Bennet, BSc MBBS MRCOG
Contact
sarah.bennet25@imperial.ac.uk
07983980924
Thomas Bainton, BM BCh MRCOG MA(Oxon)
Contact
tombainton@doctors.org.uk

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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