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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-43
SponsorPoissy-Saint Germain Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • ethanol sclerotherapy

    Procedure/Surgery

    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.

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: ethanol sclerotherapy groupExperimental treatment 1 intervention
Group B: group without interventionNo intervention 0 interventions

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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