Clinical trial

Nordics and Switzerland Prospective Multicentre Non-Interventional Observational Study to Assess the Pattern of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice (NORSOS)

Name

000411

Description

Study designed to observe the usage patterns, efficacy and safety of REKOVELLE® in women naive to IVF and ICSI, undergoing their first Controlled Ovarian Stimulation (COS) treatment cycle with REKOVELLE® in routine clinical practice.

Trial arms

Trial start

2022-08-28

Estimated PCD

2024-03-14

Trial end

2024-03-14

Status

Completed

Treatment

REKOVELLE®

Subjects must be treated according to the routine clinical practice and REKOVELLE® must be prescribed in accordance with the terms of the marketing authorisation of each participating country. According to the label the REKOVELLE® dose should be based on a recent determination of body weight and a recent determination of Anti-Müllerian Hormone (AMH) (i.e. within the last 12 months) measured by the following diagnostic tests: ELECSYS AMH Plus immunoassay from Roche or alternatively the ACCESS AMH Advanced from Beckman Coulter or LUMIPULSE G AMH from Fujirebio.

Arms:

REKOVELLE®

Other names:

follitropin delta

Size

201

Primary endpoint

Use of the algorithm-based individualized dosing regimen (daily dose of REKOVELLE® administered)

Up to day 1 of REKOVELLE® stimulation

Daily dose of REKOVELLE®

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

REKOVELLE® Dose changes

From day 1 up to day 20 of REKOVELLE® stimulation

Use of the Algorithm dosing Application

Up to day 1 of REKOVELLE® stimulation

Use of GnRH protocol for Lutenizing Hormone surge suppression

Up to day 10

Type of drug used for triggering of follicle maturation

Between Day 8 and Day 14

Luteal phase support

24-72 hours after oocyte-retrieval

Eligibility criteria

Inclusion Criteria: * Females aged 18 years or older at enrolment * Who have never been treated with (naïve) in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment using fresh or frozen ejaculated sperm from male partner or sperm donor * Who are prescribed REKOVELLE® for the first time, using the dosing algorithm-based on AMH test result and body weight to define the 1st cycle dose regimen with REKOVELLE® according to the approved label * Who have been informed verbally and in writing about this trial content, signed the inform consent and who do not object to their data being electronically processed Exclusion Criteria: * Currently participating in an interventional clinical trial in which any treatment or follow-up is mandated * Women with a contraindication for prescription of REKOVELLE® treatment * Hypersensitivity to the active substance or to any of the excipients * Tumours of the hypothalamus or pituitary gland * Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome * Gynaecological haemorrhages of unknown aetiology * Ovarian, uterine, or mammary carcinoma * Primary ovarian failure * Malformations of sexual organs incompatible with pregnancy * Fibroid tumours of the uterus incompatible with pregnancy * Pregnancy and breast feeding * Women who undergo ovarian stimulation for fertility preservation * Women placed under judicial protection, guardianship, or supervision * Women who are considered as vulnerable population

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 201, 'type': 'ACTUAL'}}

Updated at

2024-04-16

1 organization

1 product

1 indication

Organization

Ferring Pharmaceuticals

Product

REKOVELLE®

Indication

Controlled Ovarian Stimulation