Controlled Ovarian Stimulation
Conditions
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.
Interventions
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.
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Austria, Belgium, Canada, Germany, Italy, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed