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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follitropin Delta | Drug | 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. |
|
| 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 |
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Inclusion Criteria: Patients who meet all of the following criteria are eligible for participation:
Exclusion Criteria: Patients who meet any of the following criteria are not eligible for participation:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melbourne - IVF (there may be other sites in this country) | East Melbourne | Australia | ||||
| Landeskrankenhaus Feldkirch Kinderwunschzentrum (there may be other sites in this country) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36619578 | Result | 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. |
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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 |
| 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 |
| ID | Term |
|---|---|
| C000620228 | follitropin delta |
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