Study identification

EU PAS number

EUPAS1000000435

Study ID

1000000435

Official title and acronym

Pergoveris patients’ profile and outcome response measurement in IVF/ICSI autologous cycles (PERFORM)

DARWIN EU® study

No

Study countries

France
Germany
Greece
Italy
Norway
Romania
Spain
Switzerland

Study description

This study is a multi-center and multi-country, prospective, observational study.
The primary objective is to describe patients’ profiles for whom r-hFSH/r-hLH combination (Pergoveris) is administered in a real-world clinical setting, where treatment with ART is provided as part of routine care.
The secondary objective is to describe the OS protocols and to evaluate the outcomes of OS and IVF/ICSI cycle in patients for whom r-hFSH/r-hLH combination (Pergoveris) is given in a real-world clinical setting, where treatment with ART is provided as part of routine care

The study will include approximately 1,500 participants undergoing OS cycles with Pergoveris who consent to participate.
The study will be conducted in approximately 37 study centers across Germany, Spain, Italy, France, Switzerland, Greece, Romania, and Norway.
As this is a non-interventional study, the decision to treat patients with Pergoveris is at the discretion of the attending physician and is independent from participation in this study.
Treatment with Pergoveris should be discussed prior to and independent of discussion of study participation. Participants will be recruited for approximately 22 months. Each participant will be followed until a pregnancy test is carried out, OS failure, treatment discontinuation, or withdrawal from the study.
In case of a positive pregnancy test, each participant will be followed until a pregnancy outcome (e.g. miscarriage, termination, or live birth) occurs.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Prof. Dr. med. Stefan Kissler

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Merck Healthcare KGaA
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable