Status:
COMPLETED
Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Controlled Ovarian Stimulation
Eligibility:
FEMALE
18+ years
Brief Summary
The aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world co...
Eligibility Criteria
Inclusion
- Females aged 18 years or older at enrolment
- Who are treated for IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor
- Who are prescribed REKOVELLE for the first time and using the dosing algorithm to define the dose regimen: a previous cycle with REKOVELLE should not be allowed
- Who have been informed verbally and in writing about this study content and who do not object to their data being electronically processed.
Exclusion
- Participating in an interventional clinical trial in which any treatment or follow-up is mandated
- Women with a contraindication for prescription of REKOVELLE treatment
- Oocyte donors
- Women undergoing ovarian stimulation for fertility preservation
- Women undergoing their third or fourth attempt of IVF or ICSI for the current parental project.
- Subject non-affiliated to French Social Security
- Women placed under judicial protection, guardianship, or supervision
Key Trial Info
Start Date :
June 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04503707
Start Date
June 17 2020
End Date
October 31 2021
Last Update
December 14 2021
Active Locations (14)
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1
Hôpital Pellegrin
Bordeaux, France
2
Hôpital Femme Mère Enfant
Bron, France
3
Hopital Antoine Béclère
Clamart, France
4
Centre Hospitalier Intercommunal de Créteil
Créteil, France