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

Infertility, Female Clinical Trial

— NACRE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349190
• Other study ID #: 0001
• Status: Completed
• Start date: December 29, 2017
• Est. completion date: January 8, 2019

Study information

• Verified date: January 2019
• Source: ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

A retrospective, national, multicenter study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 8, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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:

Related Conditions & MeSH terms

• Fibroid Uterus
• Infertility
• Infertility, Female
• Leiomyoma

Intervention

Drug:
• ULIPRISTAL ACETATE
Ulipristal Acetate (Esmya) administrated for fibroids indication before surgery and IVF/ICSI procedure(retrospective study)

Locations

Country	Name	City	State
France	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	Ecully
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
New Caledonia	Centre Hospitalier Territorial Gaston Bourret	Nouméa

Sponsors (2)

Lead Sponsor	Collaborator
ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO	Gedeon Richter Plc.

Countries where clinical trial is conducted

France,  New Caledonia, 

Outcome

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