Actively Recruiting
Endometrioma Sclerotherapy and Ovarian Preservation: a Randomised Control Trial of Laparoscopic Sclerotherapy vs Traditional Excision of Endometrioma
Led by Chelsea and Westminster NHS Foundation Trust · Updated on 2025-11-25
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates women with ovarian endometrioma who are choosing surgical treatment for endometriosis. It compares two approaches: laparoscopic ethanol sclerotherapy of ovarian endometrioma versus standard laparoscopic surgical removal of endometrioma. The study aims to assess ovarian reserve, as well as endometrioma recurrence, symptoms, and inflammation, over a 24-month period following surgery. Participants will be randomly assigned to receive either laparoscopic ethanol sclerotherapy or routine laparoscopic surgical excision of the endometrioma. Any other endometriosis found during surgery will be treated as usual. The study measures ovarian reserve through blood tests for anti-Mullerian hormone (AMH) and ultrasound counts of ovarian follicles. Recurrence will be monitored by ultrasound, symptoms tracked by questionnaires, and inflammation assessed through blood samples and endometrial biopsy. Women will be followed for 24 months after surgery with regular assessments including imaging, blood tests, and symptom questionnaires. The primary outcome is ovarian reserve at 24 months. Secondary outcomes include recurrence of endometrioma, symptom changes, and inflammation levels. The study will be conducted with single blinding and aims to provide detailed monitoring of participants' ovarian function and disease status over two years.
CONDITIONS
Brief Title
Endometrioma Sclerotherapy and Ovarian Preservation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female (XX genotype, assigned female at birth)
- Age 18 to 40 years
- Suspected uni- or bi-lateral ovarian endometrioma of 2 cm or larger on transvaginal ultrasound or pelvic MRI
- Suitable for laparoscopic excision of endometrioma due to size, pain symptoms not managed by medication, or to assist assisted reproductive technology
You will not qualify if you...
- Postmenopausal status
- Suspicion of malignancy
- Unable to undergo transvaginal ultrasound scanning
- Declines to participate in the study
- Unable to understand verbal or written information in English
- Lacks capacity to consent at recruitment
- Known safeguarding issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo either laparoscopic ethanol sclerotherapy or routine laparoscopic excision of endometrioma with any concurrent endometriosis excised as per routine care.
1 surgical visit (in-person)
Duration - 24 months
Participants are followed for 24 months after surgery to assess ovarian reserve, endometrioma recurrence, symptom changes, and inflammation.
Periodic visits for assessments including transvaginal ultrasound, blood tests, questionnaires, and endometrial biopsy
Trial Site Locations
Total: 1 location
1
Chelsea and Westminster NHS Foundation Trust
London, United Kingdom, SW10 9NH
Actively Recruiting
Research Team
S
Sarah Bennet, BSc MBBS MRCOG
T
Thomas Bainton, BM BCh MRCOG MA(Oxon)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here