Impact of Esmya on Fertility to Infertile Women With Fibroids Managed With Assisted Reproduction Techniques
NACRE
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)
1 other identifier
observational
127
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2017
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2017
CompletedFirst Posted
Study publicly available on registry
November 21, 2017
CompletedStudy Start
First participant enrolled
December 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2019
CompletedJanuary 9, 2019
January 1, 2019
6 months
November 10, 2017
January 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy
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
15 days
Secondary Outcomes (8)
Spontaneous pregnancy
at least 2 months
Live birth / miscarriage
9 months
Fibroids size
Baseline (before ulipristal acetate administration) and 20 months
Surgery rate
3 months
Surgery description
3 months
- +3 more secondary outcomes
Interventions
Ulipristal Acetate (Esmya) administrated for fibroids indication before surgery and IVF/ICSI procedure(retrospective study)
Eligibility Criteria
Infertile women with fibroids managed with assisted reproduction techniques (ART)
You may qualify if:
- Age between 18 to 43 years 'old at the time of the beginning of ulipristal acetate intake
- Women with fibroid at the time of ulipristal acetate prescription
- Women with desire to have children and managed for infertility in an ART center (whatever the type of infertility treatment)
- Women having received a treatment by ulipristal acetate
- 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
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
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
Écully, 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
Noumea, New Caledonia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine RONGIERES, MD
ADEFIV & University Hospitals of Strasbourg
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the ART center of the University Hospital of Strasbourg
Study Record Dates
First Submitted
November 10, 2017
First Posted
November 21, 2017
Study Start
December 29, 2017
Primary Completion
June 30, 2018
Study Completion
January 8, 2019
Last Updated
January 9, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share