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

Overview

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.

Full Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 30, 2018

Detailed Description

A retrospective, national, multicenter study

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Clinical pregnancy
    • Time Frame: 15 days
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 43 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO
  • Collaborator
    • Gedeon Richter Plc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Catherine Rongieres, Head of the ART center of the University Hospital of Strasbourg – ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO
  • Overall Official(s)
    • Catherine RONGIERES, MD, Principal Investigator, ADEFIV & University Hospitals of Strasbourg

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