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Spots Global Cancer Trial Database for Impact of Esmya on Fertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques

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Trial Identification

Brief Title: Impact of Esmya on Fertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques

Official Title: A Retrospective, National, Multicenter Study Evaluating the Impact of Ulipristal Acetate (Esmya®) on Infertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques (ART)

Study ID: NCT03349190

Interventions

ULIPRISTAL ACETATE

Study Description

Brief Summary: Fibroid is a frequent pathology of infertile women. Its deleterious effect on the infertility would be due to the mechanical way. The interest of the resection of intramural fibroids is discussed. It is necessary to measure the indication of a myomectomy, whatever the surgical procedure. On the one hand, it may cause important potential complications, and on the other hand, the surgery does not improve the parameters of the fertility. Thus, it is a major stake to avoid the surgical operation. A decrease of the size of these fibroids by medical treatment is then a good option. When the surgical treatment is necessary, a medical pre-surgical treatment is often proposed in order to decrease the symptomatology and to reduce the size of the fibroid to facilitate the surgery. Acetate Ulipristal (UPA) has been marketed in this indication. Following the Pearl I-II studies, the first indication in France was a pre-surgical treatment for 3 months at a dose of 5 mg per day. The Pearl III and IV studies evaluated the Esmya® administration as a long-term intermittent repeated treatment, giving to it a prominent position for the long-term management of symptomatic fibroids. Furthermore, cases of pregnancy before surgery are frequently described in women with fibroids treated by UPA for a pre-IVF surgery. 5 to 10 % of women who are managed for infertility have fibroids and only 2% to 3% have this unique cause of infertility. Then, some of patients followed in ART centers have been treated by UPA to reduce the fibroids size and/or to decrease the associate symptoms. The aim of this study is to evaluate in the different French ART centers, the impact on fertilization of UPA administration for infertile women with fibroids and to describe the modalities of its prescriptions and to collect information regarding safety tolerance profile of Esmya® in this patient population.

Detailed Description: A retrospective, national, multicenter study

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Chu Angers, Angers, , France

Chu Besancon, Besançon, , France

Chu Pellegrin, Bordeaux, , France

Polyclinique Jean Villar, Bruges, , France

Centre Hospitalier Intercommunal Creteil, Créteil, , France

Chu Dijon, Dijon, , France

Clinique Val D'Ouest, Ecully, , France

Chru Lille, Lille, , France

Cpma Marseille, Marseille, , France

Imr Rocca, Marseille, , France

Chevalier, Montpellier, , France

POUGET, Montpellier, , France

CHU NICE, Nice, , France

Chu Nimes, Nîmes, , France

Ch Antoine Beclere, Paris, , France

CH TENON, Paris, , France

Maternite Bichat, Paris, , France

MENARD, Paris, , France

Port Royal - Chirurgie, Paris, , France

Chu Rennes, Rennes, , France

Cmco - University Hospitals of Strasbourg, Schiltigheim, , France

Chu Toulouse, Toulouse, , France

Centre Hospitalier Territorial Gaston Bourret, Nouméa, , New Caledonia

Contact Details

Name: Catherine RONGIERES, MD

Affiliation: ADEFIV & University Hospitals of Strasbourg

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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