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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03349190
Other study ID # 0001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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:

Study Design


Related Conditions & MeSH terms


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
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