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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
000300
Universal Trial Number (UTN)
Trial acronym
PROFILE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Controlled Ovarian Stimulation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Use of algorithm-based individualised dosing regimen to decide daily dose of REKOVELLE®
Timepoint [1] 0 0
At consultation visit where the daily dose of REKOVELLE® is decided
Primary outcome [2] 0 0
Use of the dosing App
Timepoint [2] 0 0
At consultation visit where the daily dose of REKOVELLE® is decided
Primary outcome [3] 0 0
Daily dose of REKOVELLE® in micrograms
Timepoint [3] 0 0
From day 1 up to day 20 of REKOVELLE® stimulation
Primary outcome [4] 0 0
Number of days of treatment with REKOVELLE®
Timepoint [4] 0 0
From day 1 up to day 20 of REKOVELLE® stimulation
Primary outcome [5] 0 0
Day of REKOVELLE® stimulation start
Timepoint [5] 0 0
At the day of the first REKOVELLE® injection during the ovarian stimulation treatment
Primary outcome [6] 0 0
Day of REKOVELLE® stimulation end
Timepoint [6] 0 0
At the day of the last REKOVELLE® injection during the ovarian stimulation treatment
Primary outcome [7] 0 0
Type of GnRH used for Lutenizing Hormone(LH) surge suppression
Timepoint [7] 0 0
At consultation visit where the LH surge suppression protocol is decided
Primary outcome [8] 0 0
Day of LH surge suppression protocol start
Timepoint [8] 0 0
At the day of the first GnRH administration during the ovarian stimulation treatment
Primary outcome [9] 0 0
Day of LH surge suppression protocol end
Timepoint [9] 0 0
At the day of the last GnRH administration during the ovarian stimulation treatment
Primary outcome [10] 0 0
Type of drug used for the triggering of follicle maturation
Timepoint [10] 0 0
At consultation visit where the triggering of follicle maturation protocol is decided
Primary outcome [11] 0 0
Date of administration of hCG and/or GnRH for follicle maturation
Timepoint [11] 0 0
At the day of administration (at the discretion of the investigator)
Primary outcome [12] 0 0
Type of drug used for Luteal phase support
Timepoint [12] 0 0
From ovum pick-up day (the length of luteal phase support is decided at the discretion of the investigator)
Primary outcome [13] 0 0
Parameters used to define the daily dose of REKOVELLE® in case a new assisted reproductive technology treatment is initiated
Timepoint [13] 0 0
At consultation visit where the ovarian stimulation treatment strategy is decided

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/07/2020
Sample size
Target
Accrual to date
Final
1018
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melbourne - IVF (there may be other sites in this country) - East Melbourne
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Feldkirch
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Canada
State/province [3] 0 0
Montreal,
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Italy
State/province [5] 0 0
Milan
Country [6] 0 0
Netherlands
State/province [6] 0 0
Rotterdam
Country [7] 0 0
Poland
State/province [7] 0 0
Gdansk
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ferring Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Blockeel C, Griesinger G, Rago R, Larsson P, Sonde... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT03393780