Clinical trial NCT03349190: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Fibroid Uterus
Lead sponsor: ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO
Sponsor class: OTHER
Collaborators: name: Gedeon Richter Plc.
First posted: 2017-11-21
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women with fibroids managed with assisted reproduction techniques (ART)

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 15 days
Secondary outcomes:
measure: Spontaneous pregnancy
timeFrame: at least 2 months
measure: Live birth / miscarriage
timeFrame: 9 months
measure: Fibroids size
timeFrame: Baseline (before ulipristal acetate administration) and 20 months
measure: Surgery rate
timeFrame: 3 months
measure: Surgery description
timeFrame: 3 months
measure: Description of ulipristal acetate prescription
timeFrame: 20 months
measure: Safety impact on ulipristal acetate administration
timeFrame: 20 months
measure: Ulipristal acetate safety analysis in infertile women with fibroids
timeFrame: 20 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Besançon
country: France
facility: Chu Besancon
city: Bordeaux
country: France
facility: Chu Pellegrin
city: Bruges
country: France
facility: Polyclinique Jean Villar
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal Creteil
city: Dijon
country: France
facility: Chu Dijon
city: Ecully
country: France
facility: Clinique Val D'Ouest
city: Lille
country: France
facility: Chru Lille
city: Marseille
country: France
facility: Cpma Marseille
city: Marseille
country: France
facility: Imr Rocca
city: Montpellier
country: France
facility: Chevalier
city: Montpellier
country: France
facility: POUGET
city: Nice
country: France
facility: CHU NICE
city: Nîmes
country: France
facility: Chu Nimes
city: Paris
country: France
facility: Ch Antoine Beclere
city: Paris
country: France
facility: CH TENON
city: Paris
country: France
facility: Maternite Bichat
city: Paris
country: France
facility: MENARD
city: Paris
country: France
facility: Port Royal - Chirurgie
city: Rennes
country: France
facility: Chu Rennes
city: Schiltigheim
country: France
facility: Cmco - University Hospitals of Strasbourg
city: Toulouse
country: France
facility: Chu Toulouse
city: Nouméa
country: New Caledonia
facility: Centre Hospitalier Territorial Gaston Bourret
Study officials:
affiliation: ADEFIV & University Hospitals of Strasbourg
name: Catherine RONGIERES, MD
role: PRINCIPAL_INVESTIGATOR
References: