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

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.

Study Overview

• Status: Completed
• Conditions: Controlled Ovarian Stimulation
• Intervention / Treatment: Drug: Follitropin Delta

• Study Type: Observational
• Enrollment (Actual): 1018

Contacts and Locations

Study Locations

• Australia
  • East Melbourne, Australia
    • Melbourne - IVF (there may be other sites in this country)
• Austria
  • Feldkirch, Austria
    • Landeskrankenhaus Feldkirch Kinderwunschzentrum (there may be other sites in this country)
• Belgium
  • Brussels, Belgium
    • UZ Brussel (there may be other sites in this country)
• Canada
  • Montreal,, Canada
    • Clinique - OVO (there may be other sites in this country)
• Germany
  • Berlin, Germany
    • Viva Neo Praxisklinik Sydow (there may be other sites in this country)
• Italy
  • Milan, Italy
    • Policlinico di Milano (there may be other sites in this country)
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medisch Centrum (there may be other sites in this country)
• Poland
  • Gdańsk, Poland
    • Invicta Fertility Clinic Gdansk (there may be other sites in this country)
• Spain
  • Barcelona, Spain
    • Clinica Eugin (there may be other sites in this country)
• United Kingdom
  • London, United Kingdom
    • The London Women Clinic (there may be other sites in this country)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	At consultation visit where the daily dose of REKOVELLE® is decided
Daily dose of REKOVELLE® in micrograms		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)	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	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	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	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	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	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	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	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	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.	At consultation visit where the ovarian stimulation treatment strategy is decided

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2018
• Primary Completion (ACTUAL): April 17, 2020
• Study Completion (ACTUAL): July 17, 2020

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (ACTUAL): January 9, 2018

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone
• Other Study ID Numbers: 000300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No