Controlled Ovarian StimulationPROFILENCT03393780
Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures
An observational study of Controlled Ovarian Stimulation, run by Ferring Pharmaceuticals at 10 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Controlled Ovarian Stimulation
- What is being tested?
- Follitropin Delta
- Type of treatment
- Injection or infusion
- How many people
- 1,018 participants
- Where
- 10 sitesin 10 countries
- Study dates
- 16 Mar 2018to 17 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who are prescribed REKOVELLE® within the approved indication for IVF or ICSI for their first in vitro fertilisation treatment will be invited to participate in the study. Patients will be enrolled only after the treatment decision has been made and no aspect of this study will interfere with or influence the routine medical procedures and/or medications received
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
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
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
Australia1 site
Melbourne - IVF (there may be other sites in this country)
East Melbourne
Austria1 site
Landeskrankenhaus Feldkirch Kinderwunschzentrum (there may be other sites in this country)
Feldkirch
Canada1 site
Clinique - OVO (there may be other sites in this country)
Montreal
Germany1 site
Viva Neo Praxisklinik Sydow (there may be other sites in this country)
Berlin
Italy1 site
Policlinico di Milano (there may be other sites in this country)
Milan
Netherlands1 site
Erasmus Medisch Centrum (there may be other sites in this country)
Rotterdam
Poland1 site
Invicta Fertility Clinic Gdansk (there may be other sites in this country)
Gdansk
United Kingdom1 site
The London Women Clinic (there may be other sites in this country)
London
About this study
Official 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
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.
- Conditions
- Controlled Ovarian Stimulation
- Being tested
- Follitropin Delta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin DeltaDrug
Also called REKOVELLE®
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of algorithm-based individualised dosing regimen to decide daily dose of REKOVELLE®
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
Measured: At consultation visit where the daily dose of REKOVELLE® is decided
Use of the dosing App
Use of the Ferring developed dosing app for the daily dose calculation by answering yes/no to a questionnaire
Measured: At consultation visit where the daily dose of REKOVELLE® is decided
Daily dose of REKOVELLE® in micrograms
Measured: From day 1 up to day 20 of REKOVELLE® stimulation
Number of days of treatment with REKOVELLE®
Adjusted during the stimulation based on blood sample of Oestrogen levels and number of follicles (at the discretion of the investigator)
Measured: From day 1 up to day 20 of REKOVELLE® stimulation
Day of REKOVELLE® stimulation start
The time point of the start of the stimulation is decided at the discretion of the investigator
Measured: At the day of the first REKOVELLE® injection during the ovarian stimulation treatment
Day of REKOVELLE® stimulation end
The time point of the end of the stimulation is decided at the discretion of the investigator
Measured: At the day of the last REKOVELLE® injection during the ovarian stimulation treatment
Type of GnRH used for Lutenizing Hormone(LH) surge suppression
Defined as a choice between GnRH agonist and GnRH antagonist
Measured: At consultation visit where the LH surge suppression protocol is decided
Day of LH surge suppression protocol start
The time point of the start of LH surge suppression is decided at the discretion of the investigator
Measured: At the day of the first GnRH administration during the ovarian stimulation treatment
Day of LH surge suppression protocol end
The time point of the end of LH surge suppression is decided at the discretion of the investigator
Measured: At the day of the last GnRH administration during the ovarian stimulation treatment
Type of drug used for the triggering of follicle maturation
Decided as a choice between hCG and/or GnRH
Measured: At consultation visit where the triggering of follicle maturation protocol is decided
Date of administration of hCG and/or GnRH for follicle maturation
Date when the investigator decides to trigger the final follicle maturation
Measured: At the day of administration (at the discretion of the investigator)
Type of drug used for Luteal phase support
Decided as a choice between Progesterone, Oestrogen and hCG
Measured: From ovum pick-up day (the length of luteal phase support is decided at the discretion of the investigator)
Parameters used to define the daily dose of REKOVELLE® in case a new assisted reproductive technology treatment is initiated
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.
Measured: At consultation visit where the ovarian stimulation treatment strategy is decided
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start16 Mar 2018
- Primary completion17 Apr 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Controlled Ovarian StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393780
- Sponsor's protocol ID
- 000300
- Acronym
- PROFILE
- Status last verified
- Nov 2020
- First submitted
- 13 Dec 2017
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36619578
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03393780
- Acronym / sponsor ID
- PROFILE / 000300
- Conditions
- Controlled Ovarian Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are prescribed REKOVELLE® within the approved indication for IVF or ICSI for their first in vitro fertilisation treatment will be invited to participate in the study. Patients will be enrolled only after the treatment decision has been made and no aspect of this study will interfere with or influence the routine medical procedures and/or medications received
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follitropin DeltaAlso: REKOVELLE®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. | Drug | – |
Primary outcome
Use of algorithm-based individualised dosing regimen to decide daily dose of REKOVELLE®
Time frame: At consultation visit where the daily dose of REKOVELLE® is decided
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
Use of the dosing App
Time frame: At consultation visit where the daily dose of REKOVELLE® is decided
Use of the Ferring developed dosing app for the daily dose calculation by answering yes/no to a questionnaire
Daily dose of REKOVELLE® in micrograms
Time frame: From day 1 up to day 20 of REKOVELLE® stimulation
Number of days of treatment with REKOVELLE®
Time frame: From day 1 up to day 20 of REKOVELLE® stimulation
Adjusted during the stimulation based on blood sample of Oestrogen levels and number of follicles (at the discretion of the investigator)
Day of REKOVELLE® stimulation start
Time frame: At the day of the first REKOVELLE® injection during the ovarian stimulation treatment
The time point of the start of the stimulation is decided at the discretion of the investigator
Day of REKOVELLE® stimulation end
Time frame: At the day of the last REKOVELLE® injection during the ovarian stimulation treatment
The time point of the end of the stimulation is decided at the discretion of the investigator
Type of GnRH used for Lutenizing Hormone(LH) surge suppression
Time frame: At consultation visit where the LH surge suppression protocol is decided
Defined as a choice between GnRH agonist and GnRH antagonist
Day of LH surge suppression protocol start
Time frame: At the day of the first GnRH administration during the ovarian stimulation treatment
The time point of the start of LH surge suppression is decided at the discretion of the investigator
Day of LH surge suppression protocol end
Time frame: At the day of the last GnRH administration during the ovarian stimulation treatment
The time point of the end of LH surge suppression is decided at the discretion of the investigator
Type of drug used for the triggering of follicle maturation
Time frame: At consultation visit where the triggering of follicle maturation protocol is decided
Decided as a choice between hCG and/or GnRH
Date of administration of hCG and/or GnRH for follicle maturation
Time frame: At the day of administration (at the discretion of the investigator)
Date when the investigator decides to trigger the final follicle maturation
Type of drug used for Luteal phase support
Time frame: From ovum pick-up day (the length of luteal phase support is decided at the discretion of the investigator)
Decided as a choice between Progesterone, Oestrogen and hCG
Parameters used to define the daily dose of REKOVELLE® in case a new assisted reproductive technology treatment is initiated
Time frame: At consultation visit where the ovarian stimulation treatment strategy is decided
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Results publication: PubMed 36619578Blockeel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Controlled Ovarian Stimulation, run by Ferring Pharmaceuticals at 10 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, Austria, Belgium, Canada, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of algorithm-based individualised dosing regimen to decide daily dose of REKOVELLE® (time frame: At consultation visit where the daily dose of REKOVELLE® is decided). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.