Benefit of Ethanol Sclerotherapy of Endometriomas Before Ovarian Stimulation on Pregnancy Rates in IVF/ICSI
SCLERENDO
1 other identifier
interventional
174
0 countries
N/A
Brief Summary
Evaluation of progressive pregnancy rates (with an embryo with cardiac activity at 12 weeks), on a first attempt at IVF/ICSI (fresh and frozen embryo transfers) following the discovery of one or two endometrioma(s) of 30 to 80 mm, without a history of cystectomy, and comparison between the two groups: ethanol sclerotherapy and therapeutic abstention
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
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
March 10, 2025
CompletedFirst Posted
Study publicly available on registry
March 14, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
March 14, 2025
March 1, 2025
4 years
March 10, 2025
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
cumulative rate of active pregnancies
Cumulative rate of active pregnancies defined by the presence of an embryo with cardiac activity at 12 weeks per IVF/ICSI cycle, including fresh and frozen embryo transfers in an IVF/ICSI attempt.
12 weeks
Study Arms (2)
ethanol sclerotherapy group
EXPERIMENTALgroup without intervention
NO INTERVENTIONInterventions
The originality of this project consists in evaluating the effectiveness of ethanol sclerotherapy of endometrioma(s) in infertile patients before IVF/ICSI, excluding patients who have previously had an ovarian cystectomy. To date, no prospective randomized comparative study between ethanol sclerotherapy of endometriomas and therapeutic abstention has been carried out.
Eligibility Criteria
You may qualify if:
- Infertile women aged 18 to 43,
- Presenting one or 2 endometriotic cysts of 30 mm to 80 mm long axis, confirmed by ultrasound and/or pelvic MRI and without signs of atypia,
- With indication of IVF/ICSI, first IVF/ICSI after the discovery of endometriosis cyst(s),
- Having given their consent.
You may not qualify if:
- A history of ovarian cystectomy,
- A non-homogeneous cyst that cannot be punctured (risk of incomplete aspiration),
- Complex adnexal image that cannot exclude an associated hematosalpinx (communicating hematosalpinx, tissue component),
- A recent tubo-ovarian infection,
- An active, untreated vaginal infection,
- Anticoagulant treatment at a therapeutic dose,
- All adult patients protected by law (under guardianship or curatorship),
- Problems understanding the French language,
- Participation in intervention research,
- All patients not affiliated to the social security system.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 10, 2025
First Posted
March 14, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
March 14, 2025
Record last verified: 2025-03