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OpenTrials
Completed

NCT Number: NCT03393780

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

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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Key information

Conditions

Controlled Ovarian Stimulation

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Melbourne - IVF (there may be other sites in this country), East Melbourne, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follitropin delta

Drug

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 names: REKOVELLE®

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: PROFILE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2018
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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