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

NCT03393780 | Completed

• 1 other identifier: 000300
• Study Type: observational
• Target: 1,018
• Locations: 9 countries
• Sites: 9

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.

Conditions

Controlled Ovarian Stimulation

Outcome Measures

Primary Outcomes (13)

• 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

Interventions

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.

Also known as: REKOVELLE®

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (10)

Melbourne - IVF (there may be other sites in this country)

East Melbourne, Australia

Location

Landeskrankenhaus Feldkirch Kinderwunschzentrum (there may be other sites in this country)

Feldkirch, Austria

Location

UZ Brussel (there may be other sites in this country)

Brussels, Belgium

Location

Clinique - OVO (there may be other sites in this country)

Montreal, Canada

Location

Viva Neo Praxisklinik Sydow (there may be other sites in this country)

Berlin, Germany

Location

Policlinico di Milano (there may be other sites in this country)

Milan, Italy

Location

Erasmus Medisch Centrum (there may be other sites in this country)

Rotterdam, Netherlands

Location

Invicta Fertility Clinic Gdansk (there may be other sites in this country)

Gdansk, Poland

Location

Clinica Eugin (there may be other sites in this country)

Barcelona, Spain

Location

The London Women Clinic (there may be other sites in this country)

London, United Kingdom

Location

Related 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 PROFILE study). Front Endocrinol (Lausanne). 2022 Dec 22;13:992677. doi: 10.3389/fendo.2022.992677. eCollection 2022.

  PMID: 36619578 RESULT

MeSH Terms

Interventions

follitropin delta

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: January 9, 2018
• Study Start: March 16, 2018
• Primary Completion: April 17, 2020
• Study Completion: July 17, 2020
• Last Updated: February 9, 2023

Record last verified: 2020-11

Locations

PL (1); DE (1); BE (1); GB (1); NL (1); AU (1); ES (1); IT (1); CA (1)