Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures
- Conditions
- Controlled Ovarian Stimulation
- Registration Number
- NCT03393780
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1018
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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Use of algorithm-based individualised dosing regimen to decide daily dose of REKOVELLE® 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 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 From day 1 up to day 20 of REKOVELLE® stimulation Number of days of treatment with REKOVELLE® 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 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 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 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 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 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Policlinico di Milano (there may be other sites in this country)
🇮🇹Milan, Italy
Invicta Fertility Clinic Gdansk (there may be other sites in this country)
🇵🇱Gdańsk, Poland
Erasmus Medisch Centrum (there may be other sites in this country)
🇳🇱Rotterdam, Netherlands
Clinique - OVO (there may be other sites in this country)
🇨🇦Montreal,, Canada
Melbourne - IVF (there may be other sites in this country)
🇦🇺East Melbourne, Australia
Viva Neo Praxisklinik Sydow (there may be other sites in this country)
🇩🇪Berlin, Germany
Landeskrankenhaus Feldkirch Kinderwunschzentrum (there may be other sites in this country)
🇦🇹Feldkirch, Austria
UZ Brussel (there may be other sites in this country)
🇧🇪Brussels, Belgium
The London Women Clinic (there may be other sites in this country)
🇬🇧London, United Kingdom
Clinica Eugin (there may be other sites in this country)
🇪🇸Barcelona, Spain