Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings
PROFOUND
Prospective, Multi-country, Non-Interventional Study to Investigate REKOVELLE for Ovarian Stimulation: the Effectiveness, Safety, and Patterns Of Use for Asian Women in Real World Practice
1 other identifier
observational
1,500
5 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Typical duration for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2024
CompletedFirst Posted
Study publicly available on registry
August 20, 2024
CompletedStudy Start
First participant enrolled
August 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
February 17, 2026
September 1, 2025
2.7 years
August 6, 2024
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative live birth rate
Cumulative live birth rate defined as delivery of at least 1 live fetus after 20 completed weeks of gestation, combined fresh and frozen embryo transfers within 12 months after the start of the ovarian stimulation in patients of the first REKOVELLE ovarian stimulation cycle.
Up to 12 months
Secondary Outcomes (29)
The Luteinising hormone (LH) surge suppression protocol
Up to 22 days
Daily Dosage
Up to 22 days
Stimulation Duration
Up to 22 days
Total Dosage
Up to 22 days
Trigger Protocol
Up to 22 days
- +24 more secondary outcomes
Study Arms (1)
REKOVELLE
Participants prescribed REKOVELLE for the first time for controlled ovarian stimulation.
Interventions
Eligibility Criteria
Approximately 1500 patients prescribed REKOVELLE for the first time for controlled overian stimulation (COS) will be enrolled in the study.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Ferring Investigational Site
Chiba, Chiba, 2610023, Japan
Ferring Investigational Site
Fukuoka, Fukuoka, 8120013, Japan
Ferring Investigational Site
Kitakyushu, Fukuoka, 8070825, Japan
Ferring Investigational Site
Takasaki, Gunma, 3700841, Japan
Ferring Investigational Site
Hiroshima, Hiroshima, 7320822, Japan
Ferring Investigational Site
Bunkyō City, Japan, 1130033, Japan
Ferring Investigational Site
Tokyo, Tokyo, 1600023, Japan
Ferring Investigational Site
Hiroshima, 7300035, Japan
Ferring Investigational Site
Hokkaido, 0600003, Japan
Ferring Investigational Site
Hyōgo, 6500021, Japan
Ferring Investigational Site
Osaka, 5300011, Japan
Ferring Investigational Site
Osaka, 5500015, Japan
Ferring Investigational Site
Saitama, 3540035, Japan
Ferring Investigational Site
Busan, Busan, 49241, South Korea
Ferring Investigational Site
Daegu, Daegu, 41910, South Korea
Ferring Investigational Site
Seongnam-si, Seongnam, 13496, South Korea
Ferring Investigational Site
Busan, 47245, South Korea
Maria Fertility Hospital
Seoul, 02586, South Korea
Ferring Investigational Site
Tainan, Tainan, 70403, Taiwan
Ferring Investigational Site
Tainan, Tainan, 71004, Taiwan
Ferring Investigational Site
Taoyuan District, Taoyuan, 333, Taiwan
Ferring Investigational Site
Taichung, 406, Taiwan
Ferring Investigational Site
Taipei, 100225, Taiwan
Ferring Investigational Site
Taipei, 110, Taiwan
Naresuan University Hospital
Phitsanulok, Muang, 65000, Thailand
Ramathibodi Hospital
Bangkok, Ratchathewi, 10400, Thailand
Ferring Investigational Site
Bangkok, 10700, Thailand
Ferring Investigational Site
Hanoi, Hanoi, 100000, Vietnam
Ferring Investigational Site
Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam
Ferring Investigational Site
Ho Chi Minh City, Ho Chi Minh City, Vietnam
Ferring Investigational Site
Huế, Huế, 49000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Compliance
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2024
First Posted
August 20, 2024
Study Start
August 27, 2024
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
February 17, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share