Endometrioma Sclerotherapy and Ovarian Preservation
ENDOSAVE
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
January 15, 2025
CompletedStudy Start
First participant enrolled
February 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
November 25, 2025
November 1, 2025
2.9 years
December 12, 2024
November 24, 2025
Conditions
Keywords
Outcome Measures
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
24 months
Secondary Outcomes (3)
Endometrioma recurrence
24 monhts
Symptomatology
24 monhts
Inflammation
24 monhts
Study Arms (2)
Surgical Management of Endometrioma
OTHERRoutine Care
Laparoscopic Sclerotherapy
EXPERIMENTALLaparoscopic ethanol sclerotherapy of endometrioma
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chelsea and Westminster NHS Foundation Trust
London, SW10 9NH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Ultra-sonographer
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2024
First Posted
January 15, 2025
Study Start
February 21, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
November 25, 2025
Record last verified: 2025-11