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 Type
OBSERVATIONAL
Enrollment
1,018
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.
Melbourne - IVF (there may be other sites in this country)
East Melbourne, Australia
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
Clinique - OVO (there may be other sites in this country)
Montreal, Canada
Viva Neo Praxisklinik Sydow (there may be other sites in this country)
Berlin, Germany
Policlinico di Milano (there may be other sites in this country)
Milan, Italy
Erasmus Medisch Centrum (there may be other sites in this country)
Rotterdam, Netherlands
Invicta Fertility Clinic Gdansk (there may be other sites in this country)
Gdansk, Poland
Clinica Eugin (there may be other sites in this country)
Barcelona, Spain
The London Women Clinic (there may be other sites in this country)
London, United Kingdom
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
Time frame: 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
Time frame: At consultation visit where the daily dose of REKOVELLE® is decided
Daily dose of REKOVELLE® in micrograms
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At consultation visit where the ovarian stimulation treatment strategy is decided
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.