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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03393780
Registration number
NCT03393780
Ethics application status
Date submitted
13/12/2017
Date registered
9/01/2018
Date last updated
9/02/2023
Titles & IDs
Public title
Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures
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Scientific title
Prospective Multicentre Non-Interventional Study to Assess the Patterns of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
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Secondary ID [1]
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000300
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Universal Trial Number (UTN)
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Trial acronym
PROFILE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Controlled Ovarian Stimulation
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Follitropin Delta
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Use of algorithm-based individualised dosing regimen to decide daily dose of REKOVELLE®
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Assessment method [1]
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Calculated with body weight in kilograms or pounds and AMH serum level in pmoL/L or ng/ml to define the daily dose of REKOVELLE® in micrograms
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Timepoint [1]
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At consultation visit where the daily dose of REKOVELLE® is decided
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Primary outcome [2]
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Use of the dosing App
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Assessment method [2]
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Use of the Ferring developed dosing app for the daily dose calculation by answering yes/no to a questionnaire
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Timepoint [2]
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At consultation visit where the daily dose of REKOVELLE® is decided
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Primary outcome [3]
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Daily dose of REKOVELLE® in micrograms
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Assessment method [3]
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Timepoint [3]
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From day 1 up to day 20 of REKOVELLE® stimulation
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Primary outcome [4]
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Number of days of treatment with REKOVELLE®
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Assessment method [4]
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Adjusted during the stimulation based on blood sample of Oestrogen levels and number of follicles (at the discretion of the investigator)
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Timepoint [4]
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From day 1 up to day 20 of REKOVELLE® stimulation
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Primary outcome [5]
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Day of REKOVELLE® stimulation start
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Assessment method [5]
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The time point of the start of the stimulation is decided at the discretion of the investigator
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Timepoint [5]
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At the day of the first REKOVELLE® injection during the ovarian stimulation treatment
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Primary outcome [6]
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Day of REKOVELLE® stimulation end
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Assessment method [6]
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The time point of the end of the stimulation is decided at the discretion of the investigator
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Timepoint [6]
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At the day of the last REKOVELLE® injection during the ovarian stimulation treatment
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Primary outcome [7]
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Type of GnRH used for Lutenizing Hormone(LH) surge suppression
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Assessment method [7]
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Defined as a choice between GnRH agonist and GnRH antagonist
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Timepoint [7]
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At consultation visit where the LH surge suppression protocol is decided
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Primary outcome [8]
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Day of LH surge suppression protocol start
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Assessment method [8]
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The time point of the start of LH surge suppression is decided at the discretion of the investigator
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Timepoint [8]
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At the day of the first GnRH administration during the ovarian stimulation treatment
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Primary outcome [9]
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Day of LH surge suppression protocol end
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Assessment method [9]
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The time point of the end of LH surge suppression is decided at the discretion of the investigator
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Timepoint [9]
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At the day of the last GnRH administration during the ovarian stimulation treatment
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Primary outcome [10]
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Type of drug used for the triggering of follicle maturation
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Assessment method [10]
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Decided as a choice between hCG and/or GnRH
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Timepoint [10]
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At consultation visit where the triggering of follicle maturation protocol is decided
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Primary outcome [11]
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Date of administration of hCG and/or GnRH for follicle maturation
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Assessment method [11]
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Date when the investigator decides to trigger the final follicle maturation
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Timepoint [11]
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At the day of administration (at the discretion of the investigator)
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Primary outcome [12]
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Type of drug used for Luteal phase support
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Assessment method [12]
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Decided as a choice between Progesterone, Oestrogen and hCG
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Timepoint [12]
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From ovum pick-up day (the length of luteal phase support is decided at the discretion of the investigator)
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Primary outcome [13]
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Parameters used to define the daily dose of REKOVELLE® in case a new assisted reproductive technology treatment is initiated
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Assessment method [13]
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According to the Summary of Product Characteristics, the daily dose can be increased or decreased for subsequent cycles based on the patient response to the initial treatment cycle.
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Timepoint [13]
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At consultation visit where the ovarian stimulation treatment strategy is decided
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Eligibility
Key inclusion criteria
Patients who meet all of the following criteria are eligible for
participation:
- Females are prescribed REKOVELLE® for their first in vitro fertilisation (IVF) or
intracytoplasmic sperm injection (ICSI) treatment cycle using fresh or frozen
ejaculated sperm from male partner or sperm donor
- Willing and able to provide written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who meet any of the following criteria are not eligible for
participation:
- 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/07/2020
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Sample size
Target
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Accrual to date
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Final
1018
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Melbourne - IVF (there may be other sites in this country) - East Melbourne
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Recruitment postcode(s) [1]
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- East Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Feldkirch
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Country [2]
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Belgium
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State/province [2]
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Brussels
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Country [3]
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Canada
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State/province [3]
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Montreal,
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Country [4]
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Germany
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State/province [4]
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Berlin
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Country [5]
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Italy
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State/province [5]
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Milan
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Country [6]
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Netherlands
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State/province [6]
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Rotterdam
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Country [7]
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Poland
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State/province [7]
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Gdansk
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Country [8]
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Spain
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State/province [8]
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Barcelona
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Country [9]
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United Kingdom
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State/province [9]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Ferring Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to monitor the use in routine clinical practice of REKOVELLE®.
This study will collect information from patients who never underwent previous in vitro
fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatments for up to three
consecutive treatment cycles.
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT03393780
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03393780
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