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

Completed

• Conditions: Infertility, Female; Fibroid Uterus

• Registration Number: NCT03349190
• Lead Sponsor: ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO

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

Study Timeline

• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-21
• Study Start: 2017-12-29
• Primary Completion: 2018-06-30
• Status Verified: 2019-01
• Study Completion: 2019-01-08
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 127

Inclusion Criteria

1. Age between 18 to 43 years 'old at the time of the beginning of ulipristal acetate intake
2. Women with fibroid at the time of ulipristal acetate prescription
3. Women with desire to have children and managed for infertility in an ART center (whatever the type of infertility treatment)
4. Women having received a treatment by ulipristal acetate
5. Data collected between 2013/12/01 and 2018/06/30 ; data collected between ulipristal acetate prescription until the term of pregnancy or embryo transfer failure (up to 4) or death/lost to follow up or ART treatment discontinuation

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	15 days	Clinical pregnancy rate after maximum 4 embryos transferred by IVF/ICSI procedures ; pregnancy is defined by beta-hCG\> 1000 or presence of a gestation sac

Secondary Outcome Measures

Name	Time	Method
Live birth / miscarriage	9 months	Live birth rate / miscarriage rate
Spontaneous pregnancy	at least 2 months	Spontaneous pregnancy rate before first embryo transferred by IVF/ICSI procedures; pregnancy is defined by beta-hCG \> 1000 or presence of a gestation sac
Surgery rate	3 months	Rate of surgery
Safety impact on ulipristal acetate administration	20 months	Review of adverse drug reactions resulting in ulipristal acetate treatment modification or discontinuation
Ulipristal acetate safety analysis in infertile women with fibroids	20 months	Review of all serious adverse reactions (expected or unexpected) in this population
Fibroids size	Baseline (before ulipristal acetate administration) and 20 months	Fibroids size reduction
Surgery description	3 months	Description of the surgery type and surgery indication
Description of ulipristal acetate prescription	20 months	Reasons of the prescription, type of fibroids concerned, number of cycles of treatment, treatment duration

Trial Locations

Locations (23)

Chu Angers; 🇫🇷 Angers, France

Centre Hospitalier Intercommunal Creteil; 🇫🇷 Créteil, France

Chu Dijon; 🇫🇷 Dijon, France

Chu Besancon; 🇫🇷 Besançon, France

Polyclinique Jean Villar; 🇫🇷 Bruges, France

Clinique Val D'Ouest; 🇫🇷 Ecully, France

Chru Lille; 🇫🇷 Lille, France

Imr Rocca; 🇫🇷 Marseille, France

Chevalier; 🇫🇷 Montpellier, France

POUGET; 🇫🇷 Montpellier, France

Chu Nimes; 🇫🇷 Nîmes, France

Ch Antoine Beclere; 🇫🇷 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

Centre Hospitalier Territorial Gaston Bourret; 🇳🇨 Nouméa, New Caledonia

Chu Toulouse; 🇫🇷 Toulouse, France

Cpma Marseille; 🇫🇷 Marseille, France

Chu Pellegrin; 🇫🇷 Bordeaux, France

CHU NICE; 🇫🇷 Nice, France

CH TENON; 🇫🇷 Paris, France