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| Name | Class |
|---|---|
| Gedeon Richter Plc. | INDUSTRY |
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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.
A retrospective, national, multicenter study
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ULIPRISTAL ACETATE | Drug | Ulipristal Acetate (Esmya) administrated for fibroids indication before surgery and IVF/ICSI procedure(retrospective study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Live birth / miscarriage |
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Inclusion Criteria:
Exclusion Criteria:
none
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Infertile women with fibroids managed with assisted reproduction techniques (ART)
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| Name | Affiliation | Role |
|---|---|---|
| Catherine RONGIERES, MD | ADEFIV & University Hospitals of Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Angers | France | ||||
| Chu Besancon |
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Live birth rate / miscarriage rate
| 9 months |
| Fibroids size | Fibroids size reduction | Baseline (before ulipristal acetate administration) and 20 months |
| Surgery rate | Rate of surgery | 3 months |
| Surgery description | Description of the surgery type and surgery indication | 3 months |
| Description of ulipristal acetate prescription | Reasons of the prescription, type of fibroids concerned, number of cycles of treatment, treatment duration | 20 months |
| Safety impact on ulipristal acetate administration | Review of adverse drug reactions resulting in ulipristal acetate treatment modification or discontinuation | 20 months |
| Ulipristal acetate safety analysis in infertile women with fibroids | Review of all serious adverse reactions (expected or unexpected) in this population | 20 months |
| 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 |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
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