Benefit of Ethanol Sclerotherapy of Endometriomas Before Ovarian Stimulation on Pregnancy Rates in IVF/ICSI

NCT ID: NCT06878053

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2029-06-01

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

Conditions

Infertile Women Undergoing IVF or ICSI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ethanol sclerotherapy group

Group Type: EXPERIMENTAL

ethanol sclerotherapy

Intervention Type: PROCEDURE

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.

group without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ethanol sclerotherapy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Poissy-Saint Germain Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nelly SWIERKOWSKI-BLANCHARD, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nelly SWIERKOWSKI-BLANCHARD, MD

Role: CONTACT

nelly.swierkowskiblanchard@ght-yvelinesnord.fr

+33139275259

Other Identifiers

2024-A02459-38

Identifier Type: -

Identifier Source: org_study_id