Infertile Women Undergoing IVF or ICSI
Conditions
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
Interventions
PROCEDUREethanol 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.
Sponsors
Poissy-Saint Germain Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cumulative rate of active pregnancies | 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. |
Contacts
Primary ContactNelly SWIERKOWSKI-BLANCHARD, MD
Outcome results
None listed