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

NCT03349190 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2019-01-09

No results posted yet for this study

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.

Conditions

  • Infertility, Female
  • Fibroid Uterus

Interventions

DRUG

ULIPRISTAL ACETATE

Ulipristal Acetate (Esmya) administrated for fibroids indication before surgery and IVF/ICSI procedure(retrospective study)

Sponsors & Collaborators

  • Gedeon Richter Plc.

    collaborator INDUSTRY

  • ASSOCIATION POUR LE DEVELOPPEMENT EN FECONDATION IN VITRO

    lead OTHER

Principal Investigators

  • Catherine RONGIERES, MD · ADEFIV & University Hospitals of Strasbourg

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-29
Primary Completion
2018-06-30
Completion
2019-01-08

Countries

  • France
  • New Caledonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03349190 on ClinicalTrials.gov