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

Controlled Ovarian Stimulation Clinical Trial

— PROFILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393780
• Other study ID #: 000300
• Status: Completed
• Start date: March 16, 2018
• Est. completion date: July 17, 2020

Study information

• Verified date: November 2020
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1018
• Est. completion date: July 17, 2020
• Est. primary completion date: April 17, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Controlled Ovarian Stimulation

Intervention

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.

Locations

Country	Name	City	State
Australia	Melbourne - IVF (there may be other sites in this country)	East Melbourne
Austria	Landeskrankenhaus Feldkirch Kinderwunschzentrum (there may be other sites in this country)	Feldkirch
Belgium	UZ Brussel (there may be other sites in this country)	Brussels
Canada	Clinique - OVO (there may be other sites in this country)	Montreal,
Germany	Viva Neo Praxisklinik Sydow (there may be other sites in this country)	Berlin
Italy	Policlinico di Milano (there may be other sites in this country)	Milan
Netherlands	Erasmus Medisch Centrum (there may be other sites in this country)	Rotterdam
Poland	Invicta Fertility Clinic Gdansk (there may be other sites in this country)	Gdansk
Spain	Clinica Eugin (there may be other sites in this country)	Barcelona
United Kingdom	The London Women Clinic (there may be other sites in this country)	London

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Canada,  Germany,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Daily dose of REKOVELLE® in micrograms		From day 1 up to day 20 of REKOVELLE® stimulation
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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