Study identification

PURI

https://redirect.ema.europa.eu/resource/49075

EU PAS number

EUPAS41175

Study ID

49075

Official title and acronym

A non-interventional register-based comparative effectiveness study of rhFSH-alfa reference product vs. highly purified human menopausal gonadotropin or rhFSH-alfa biosimilar products for ovarian stimulation in in vitro fertilization or intracytoplasmic sperm injection treatment in Denmark and Sweden – The Nordic Follitropin Alfa Comparative Effectiveness Study (NORD-FACE)

DARWIN EU® study

No

Study countries

Denmark
Sweden

Study description

The urinary gonadotropins had been used universally until the introduction of recombinant technology. Even if this technology had shown improvement in purity, consistency, and specific activity of gonadotropin products, both types of products, urinary and recombinant gonadotropins, are on the market at the present. From a clinical perspective, the decision regarding what kind of gonadotropin to give to a woman undergoing a treatment for fertility is still challenging. One of the points to consider is the possible differences in effectiveness among the different gonadotropins. This non-interventional study is based on secondary data from national population-based registers with prospective data collection in Denmark and Sweden. The study uses a cohort design and is conducted as a comparative effectiveness and safety study with head-to-head comparisons of drugs used for treatment of infertility and in assisted reproductive technology (ART). The study drugs are rhFSH-alfa reference product (drug of interest), HP-hMG and rhFSH-alfa biosimilar products (comparator drugs). The primary objective is to compare rhFSH-alfa reference product with HP-hMG or rhFSH-alfa biosimilar products regarding live birth outcomes. The overall study population includes women, aged 18 years or older, who initiated IVF/ICSI stimulation cycle with rhFSH-alfa reference product, HP-hMG, or rhFSH-alfa biosimilar product monotherapy for controlled ovarian stimulation (COS), 2010-2020. Different study periods are applied for the comparison of rhFSH-alfa reference product with, respectively, HP-hMG (2010-2020) and rhFSH-alfa biosimilar products (2014-2020).

Study status

Finalised
Research institution and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution
Non-Pharmaceutical companyENCePP partner

Contact details

Mickael Arnaud

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

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Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Merck Healthcare KGaA
Study protocol
Initial protocol

Protocol-Merck_NORD-FACE_Study_v1.0_27May2021

English (6.22 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable