Status:
RECRUITING
Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
20+ years
Brief Summary
Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.
Eligibility Criteria
Inclusion
- Females aged 20 years or older at enrollment
- Serum AMH level \>0.5 ng / mL (with the latest result tested within 12 months)
- Who are first time prescribed REKOVELLE for their ovarian stimulation and IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor (if applicable)
- Willing and able to provide written informed consent
Exclusion
- Have undergone more than 2 COS-IVF / ICSI cycles before the enrollment
- Participating in an interventional clinical trial in which any medication treatment is mandated
- Women with a contraindication for prescription of REKOVELLE treatment
- Oocyte donors
- Undergoing ovarian stimulation for fertility preservation
Key Trial Info
Start Date :
August 27 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06561958
Start Date
August 27 2024
End Date
August 1 2027
Last Update
September 24 2025
Active Locations (31)
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1
Ferring Investigational Site
Chiba, Chiba, Japan, 2610023
2
Ferring Investigational Site
Fukuoka, Fukuoka, Japan, 8120013
3
Ferring Investigational Site
Kitakyushu, Fukuoka, Japan, 8070825
4
Ferring Investigational Site
Takasaki, Gunma, Japan, 3700841