Infertility, Female Clinical Trial
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)
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.
A retrospective, national, multicenter study ;
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