NCT03349190

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 127 (actual)
• Sponsor: ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

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

Conditions

• Infertility, Female
• Fibroid Uterus

Interventions

Type	Name	Description
DRUG	ULIPRISTAL ACETATE	Ulipristal Acetate (Esmya) administrated for fibroids indication before surgery and IVF/ICSI procedure(retrospective study)

Timeline

• Start date: 2017-12-29
• Primary completion: 2018-06-30
• Completion: 2019-01-08
• First posted: 2017-11-21
• Last updated: 2019-01-09

Locations

23 sites across 2 countries: France, New Caledonia