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

P

Poissy-Saint Germain Hospital

Status

Not yet enrolling

Conditions

Infertile Women Undergoing IVF or ICSI

Treatments

Procedure: ethanol sclerotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06878053
2024-A02459-38

Details and patient eligibility

About

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

Enrollment

174 estimated patients

Sex

Female

Ages

18 to 43 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

174 participants in 2 patient groups

ethanol sclerotherapy group
Experimental group
Treatment:
Procedure: ethanol sclerotherapy
group without intervention
No Intervention group

Trial contacts and locations

0

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Central trial contact

Nelly SWIERKOWSKI-BLANCHARD, MD

Data sourced from clinicaltrials.gov

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