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Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures (PROFILE)

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ClinicalTrials.gov Identifier: NCT03393780
Recruitment Status : Active, not recruiting
First Posted : January 9, 2018
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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.


Condition or disease Intervention/treatment
Controlled Ovarian Stimulation Drug: Follitropin Delta

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Study Type : Observational
Actual Enrollment : 1018 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : April 17, 2020
Estimated Study Completion Date : December 2020

Intervention Details:
  • Drug: 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 Name: REKOVELLE®


Primary Outcome Measures :
  1. 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

  2. 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

  3. Daily dose of REKOVELLE® in micrograms [ Time Frame: From day 1 up to day 20 of REKOVELLE® stimulation ]
  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393780


Locations
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Australia
Melbourne - IVF (there may be other sites in this country)
East Melbourne, Australia
Austria
Landeskrankenhaus Feldkirch Kinderwunschzentrum (there may be other sites in this country)
Feldkirch, Austria
Belgium
UZ Brussel (there may be other sites in this country)
Brussels, Belgium
Canada
Clinique - OVO (there may be other sites in this country)
Montreal,, Canada
Germany
Viva Neo Praxisklinik Sydow (there may be other sites in this country)
Berlin, Germany
Italy
Policlinico di Milano (there may be other sites in this country)
Milan, Italy
Netherlands
Erasmus Medisch Centrum (there may be other sites in this country)
Rotterdam, Netherlands
Poland
Invicta Fertility Clinic Gdansk (there may be other sites in this country)
Gdańsk, Poland
Spain
Clinica Eugin (there may be other sites in this country)
Barcelona, Spain
United Kingdom
The London Women Clinic (there may be other sites in this country)
London, United Kingdom
Sponsors and Collaborators
Ferring Pharmaceuticals
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03393780    
Other Study ID Numbers: 000300
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs