EndometriomaENDOSAVENCT06775769
Endometrioma Sclerotherapy and Ovarian Preservation
A study testing Sclerotherapy and Routine Care in people with Endometrioma, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrioma
- What is being tested?
- Sclerotherapy and Routine Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Bainton, BM BCh MRCOG MA(Oxon) contact
United Kingdom1 site, 1 recruiting
- Recruiting
Chelsea and Westminster NHS Foundation Trust
London, SW10 9NH
Gulsah Cetinkaya, 020 3315 6646, gulsah.cetinkaya1@nhs.net
About this study
Official title: Endometrioma Sclerotherapy and Ovarian Preservation: a Randomised Control Trial of Laparoscopic Sclerotherapy vs Traditional Excision of Endometrioma
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.
- Conditions
- Endometrioma
- Being tested
- Sclerotherapy, Routine Care
- Keywords
- Endometrioma, Endometriosis, Sclerotherapy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SclerotherapyProcedure or surgery
Laparoscopic ethanol sclerotherapy of endometrioma
Routine CareProcedure or surgery
Routine surgical management of endometrioma
| Study group | Role | What they receive |
|---|---|---|
| Surgical Management of Endometrioma | Other | Routine Care Receives: Procedure: Routine Care |
| Laparoscopic Sclerotherapy | Experimental | Laparoscopic ethanol sclerotherapy of endometrioma Receives: Procedure: Sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (3)
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
Measured: 24 monhts
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
Measured: 24 monhts
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
Measured: 24 monhts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start21 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775769
- Sponsor's protocol ID
- 24/LO/0825
- Acronym
- ENDOSAVE
- Status last verified
- Nov 2025
- First submitted
- 12 Dec 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrioma Sclerotherapy and Ovarian Preservation: a Randomised Control Trial of Laparoscopic Sclerotherapy vs Traditional Excision of Endometrioma
- ClinicalTrials.gov ID
- NCT06775769
- Acronym / sponsor ID
- ENDOSAVE / 24/LO/0825
- Conditions
- Endometrioma
- Keywords
- Endometrioma, Endometriosis, Sclerotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Surgical Management of Endometrioma | Other | Procedure: Routine CareRoutine Care |
| Laparoscopic Sclerotherapy | Experimental | Procedure: SclerotherapyLaparoscopic ethanol sclerotherapy of endometrioma |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SclerotherapyLaparoscopic ethanol sclerotherapy of endometrioma | Procedure or surgery | Laparoscopic Sclerotherapy |
| Routine CareRoutine surgical management of endometrioma | Procedure or surgery | Surgical Management of Endometrioma |
Primary outcome
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
3 secondary outcomes
Endometrioma recurrence
Time frame: 24 monhts
Symptomatology
Time frame: 24 monhts
Inflammation
Time frame: 24 monhts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Bainton, BM BCh MRCOG MA(Oxon) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sclerotherapy and Routine Care in people with Endometrioma, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Bennet, BSc MBBS MRCOG (07983980924, sarah.bennet25@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian Reserve (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.