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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
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
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Catherine RONGIERES, MD
Affiliation: ADEFIV & University Hospitals of Strasbourg
Role: PRINCIPAL_INVESTIGATOR