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

Study summary

No information provided.

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

Merck Healthcare KGaA

Germany

Study timelines

Date when funding contract was signed

Planned:03/06/2024

Actual:03/06/2024

Study start date

Planned:20/08/2024

Actual:20/08/2024

Data analysis start date

Planned:29/10/2027

Date of final study report

Planned:15/03/2028

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

Other study registration identification numbers and links

MS200061_0073