Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
NCT ID: NCT04503707
Last Updated: 2021-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2020-06-17
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Follitropin Delta
Treatment according to routine clinical practice.
Follitropin Delta
The Intervention (solution for injection) is delivered with a pre-filled injection pen. The REKOVELLE dose will be based on a recent determination (within the last 12 months) of AMH (anti- müllerian hormone) measured by the ELECSYS AMH Plus Immunoassay.
Interventions
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Follitropin Delta
The Intervention (solution for injection) is delivered with a pre-filled injection pen. The REKOVELLE dose will be based on a recent determination (within the last 12 months) of AMH (anti- müllerian hormone) measured by the ELECSYS AMH Plus Immunoassay.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Hôpital Pellegrin
Bordeaux, , France
Hôpital Femme Mère Enfant
Bron, , France
Hopital Antoine Béclère
Clamart, , France
Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Centre hospitalier de Lille-Hopital de Flandre
Lille, , France
Institut de Médecine de la Reproduction (there may be other sites in this country)
Marseille, , France
CHU Montpellier
Montpellier, , France
CHU Nantes Hôpital Hôtel Dieu
Nantes, , France
Maternité Port Royal
Paris, , France
Centre Hospitalier Intercommunal de Poissy
Poissy, , France
Clinique Mutualiste La Sagesse
Rennes, , France
Pierre OGER
Rueil-Malmaison, , France
CMCO
Strasbourg, , France
CHU Toulouse - Hôpital Paule de Viguier
Toulouse, , France
Countries
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Other Identifiers
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000370
Identifier Type: -
Identifier Source: org_study_id