Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures
NCT ID: NCT03393780
Last Updated: 2023-02-09
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
1018 participants
OBSERVATIONAL
2018-03-16
2020-07-17
Brief Summary
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The ovarian stimulation protocol with REKOVELLE®, a new recombinant human Follicle Stimulating Hormone (FSH) prescribed for ovarian stimulation, is individualised with a dosing regimen that is based on two parameters: the body weight and the level of a hormone, the Anti Müllerian Hormone, (AMH), a parameter used to predict how the ovaries will respond to the ovarian stimulation.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Follitropin Delta
The Intervention (solution for injection) is delivered with an injection pen. The REKOVELLE® dose will be based on recent determination (within the last 12 months) of AMH (anti- müllerian hormone) measured by the following diagnostic test from ROCHE: ELECSYS AMH Plus immunoassay.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide written informed consent
Exclusion Criteria
* Women with a contraindication for prescription of REKOVELLE® treatment
* Oocyte donors
* Women undergoing ovarian stimulation for fertility preservation
18 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Melbourne - IVF (there may be other sites in this country)
East Melbourne, , Australia
Landeskrankenhaus Feldkirch Kinderwunschzentrum (there may be other sites in this country)
Feldkirch, , Austria
UZ Brussel (there may be other sites in this country)
Brussels, , Belgium
Clinique - OVO (there may be other sites in this country)
Montreal, , Canada
Viva Neo Praxisklinik Sydow (there may be other sites in this country)
Berlin, , Germany
Policlinico di Milano (there may be other sites in this country)
Milan, , Italy
Erasmus Medisch Centrum (there may be other sites in this country)
Rotterdam, , Netherlands
Invicta Fertility Clinic Gdansk (there may be other sites in this country)
Gdansk, , Poland
Clinica Eugin (there may be other sites in this country)
Barcelona, , Spain
The London Women Clinic (there may be other sites in this country)
London, , United Kingdom
Countries
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References
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Blockeel C, Griesinger G, Rago R, Larsson P, Sonderegger YLY, Riviere S, Laven JSE. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Front Endocrinol (Lausanne). 2022 Dec 22;13:992677. doi: 10.3389/fendo.2022.992677. eCollection 2022.
Other Identifiers
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000300
Identifier Type: -
Identifier Source: org_study_id
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