Clinical trial

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

Name

000300

Description

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.

Trial arms

Trial start

2018-03-16

Estimated PCD

2020-04-17

Trial end

2020-07-17

Status

Completed

Treatment

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.

Other names:

REKOVELLE®

Size

1018

Primary endpoint

Use of algorithm-based individualised dosing regimen to decide daily dose of REKOVELLE®

At consultation visit where the daily dose of REKOVELLE® is decided

Use of the dosing App

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®

From day 1 up to day 20 of REKOVELLE® stimulation

Day of REKOVELLE® stimulation start

At the day of the first REKOVELLE® injection during the ovarian stimulation treatment

Day of REKOVELLE® stimulation end

At the day of the last REKOVELLE® injection during the ovarian stimulation treatment

Type of GnRH used for Lutenizing Hormone(LH) surge suppression

At consultation visit where the LH surge suppression protocol is decided

Day of LH surge suppression protocol start

At the day of the first GnRH administration during the ovarian stimulation treatment

Day of LH surge suppression protocol end

At the day of the last GnRH administration during the ovarian stimulation treatment

Type of drug used for the triggering of follicle maturation

At consultation visit where the triggering of follicle maturation protocol is decided

Date of administration of hCG and/or GnRH for follicle maturation

At the day of administration (at the discretion of the investigator)

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)

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

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1018, 'type': 'ACTUAL'}}

Updated at

2023-02-09

1 organization

1 product

1 indication

Organization

Ferring Pharmaceuticals

Product

Follitropin Delta

Indication

Controlled Ovarian Stimulation