Study identification

EU PAS number

EUPAS17328

Study ID

41256

Official title and acronym

Safety of Ovaleap® (Follitropin alfa) in Infertile Women Undergoing Superovulation for Assisted Reproductive Technologies. A Multi-National, Comparative, Prospective, Non-Interventional, Observational Cohort Study (SOFIA)

DARWIN EU® study

No

Study countries

Belgium
France
Germany
Italy
Spain
United Kingdom

Study description

The EMA has requested post authorization safety data to examine the risk of Ovarian Hyperstimulation Syndrome (OHSS), a potentially serious adverse effect under treatment with recombinant human follicle stimulating hormone (r-hFSH), in Ovaleap® compared to Gonal-f®.
An observational Post-Authorisation Safety Study (PASS) will therefore be performed. This is a multi-national, comparative, prospective, non interventional, observational cohort study.
The study population will comprise infertile women, who have not previously received treatment with any FSH or any product containing FSH activity, and who are undergoing Assisted Reproductive Technology (ART) and are administered Ovaleap or Gonal-f for ovarian stimulation according to site standard of care.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 56 centres are involved in the study

Contact details

George Haralabopoulos

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Theramex HQ UK Ltd
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)