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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Controlled Ovarian Stimulation

Intervention / Treatment
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* Drug: Follitropin Delta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Follitropin Delta|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.|

What is the study measuring?
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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 |