Clinical trial NCT03393780: Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Controlled Ovarian Stimulation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-01-09
Enrollment: 1018
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Use of algorithm-based individualised dosing regimen to decide daily dose of REKOVELLE®
timeFrame: At consultation visit where the daily dose of REKOVELLE® is decided
measure: Use of the dosing App
timeFrame: At consultation visit where the daily dose of REKOVELLE® is decided
measure: Daily dose of REKOVELLE® in micrograms
timeFrame: From day 1 up to day 20 of REKOVELLE® stimulation
measure: Number of days of treatment with REKOVELLE®
timeFrame: From day 1 up to day 20 of REKOVELLE® stimulation
measure: Day of REKOVELLE® stimulation start
timeFrame: At the day of the first REKOVELLE® injection during the ovarian stimulation treatment
measure: Day of REKOVELLE® stimulation end
timeFrame: At the day of the last REKOVELLE® injection during the ovarian stimulation treatment
measure: Type of GnRH used for Lutenizing Hormone(LH) surge suppression
timeFrame: At consultation visit where the LH surge suppression protocol is decided
measure: Day of LH surge suppression protocol start
timeFrame: At the day of the first GnRH administration during the ovarian stimulation treatment
measure: Day of LH surge suppression protocol end
timeFrame: At the day of the last GnRH administration during the ovarian stimulation treatment
measure: Type of drug used for the triggering of follicle maturation
timeFrame: At consultation visit where the triggering of follicle maturation protocol is decided
measure: Date of administration of hCG and/or GnRH for follicle maturation
timeFrame: At the day of administration (at the discretion of the investigator)
measure: Type of drug used for Luteal phase support
timeFrame: From ovum pick-up day (the length of luteal phase support is decided at the discretion of the investigator)
measure: Parameters used to define the daily dose of REKOVELLE® in case a new assisted reproductive technology treatment is initiated
timeFrame: At consultation visit where the ovarian stimulation treatment strategy is decided
Secondary outcomes:
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Melbourne - IVF (there may be other sites in this country)
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch Kinderwunschzentrum (there may be other sites in this country)
city: Brussels
country: Belgium
facility: UZ Brussel (there may be other sites in this country)
city: Montreal,
country: Canada
facility: Clinique - OVO (there may be other sites in this country)
city: Berlin
country: Germany
facility: Viva Neo Praxisklinik Sydow (there may be other sites in this country)
city: Milan
country: Italy
facility: Policlinico di Milano (there may be other sites in this country)
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum (there may be other sites in this country)
city: Gdańsk
country: Poland
facility: Invicta Fertility Clinic Gdansk (there may be other sites in this country)
city: Barcelona
country: Spain
facility: Clinica Eugin (there may be other sites in this country)
city: London
country: United Kingdom
facility: The London Women Clinic (there may be other sites in this country)
Study officials:
References:
citation: 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.