Endometrioma Sclerotherapy and Ovarian Preservation

NCT ID: NCT06775769

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-21

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Endometrioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Ultra-sonographer

Study Groups

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Surgical Management of Endometrioma

Routine Care

Group Type OTHER

Routine Care

Intervention Type PROCEDURE

Routine surgical management of endometrioma

Laparoscopic Sclerotherapy

Laparoscopic ethanol sclerotherapy of endometrioma

Group Type EXPERIMENTAL

Sclerotherapy

Intervention Type PROCEDURE

Laparoscopic ethanol sclerotherapy of endometrioma

Interventions

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Sclerotherapy

Laparoscopic ethanol sclerotherapy of endometrioma

Intervention Type PROCEDURE

Routine Care

Routine surgical management of endometrioma

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chelsea and Westminster NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Sarah Bennet, BSc MBBS MRCOG

Role: CONTACT

07983980924

Thomas Bainton, BM BCh MRCOG MA(Oxon)

Role: CONTACT

Facility Contacts

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Gulsah Cetinkaya

Role: primary

020 3315 6646

Other Identifiers

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24/LO/0825

Identifier Type: -

Identifier Source: org_study_id

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