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NCT Number: NCT06878053

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

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

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Key information

Conditions

Infertile Women Undergoing IVF or ICSI

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ethanol sclerotherapy

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.

Primary outcomes

  1. cumulative rate of active pregnancies

    Time frame: 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nelly SWIERKOWSKI-BLANCHARD, MD

CONTACT

[email protected]

+33139275259

Sponsors and collaborators

Lead sponsor

Poissy-Saint Germain Hospital

Other

Registry information

Acronym: SCLERENDO

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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