Investigating the effectiveness of REKOVELLE for ovarian stimulation in Asian women
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
This study is testing how well REKOVELLE works for ovarian stimulation in Asian women who are starting their first treatment for IVF or ICSI.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Ferring Pharmaceuticals Industry-sponsored |
| Locations | 18 sites (Kitakyushu, Fukuoka and 17 other locations) |
| Trial ID | NCT06561958 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of REKOVELLE® in women who are undergoing their first ovarian stimulation treatment in real-world settings across various Asian countries. The study will include females aged 20 years or older with specific eligibility criteria, including a serum AMH level above 0.5 ng/mL. Participants will be monitored as they receive REKOVELLE for their IVF or ICSI treatment cycles, allowing for an assessment of its effectiveness in a practical context. The study is non-interventional, meaning it will observe outcomes without altering standard treatment protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are females aged 20 years or older who are first-time users of REKOVELLE for ovarian stimulation.
Not a fit: Patients who have undergone more than two COS-IVF/ICSI cycles or those with contraindications for REKOVELLE treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of REKOVELLE for ovarian stimulation, potentially improving fertility treatment outcomes for Asian women.
How similar studies have performed: While this study focuses on a specific demographic and treatment, similar observational studies have shown success in evaluating fertility treatments in real-world settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Kitakyushu, Fukuoka and 17 other locations
- Ferring Investigational Site — Kitakyushu, Fukuoka, Japan (Recruiting)
- Ferring Investigational Site — Takasaki, Gunma, Japan (Recruiting)
- Ferring Investigational Site — Bunkyō-Ku, Japan (Recruiting)
- Ferring Investigational Site — Chiba, Japan (Recruiting)
- Ferring Investigational Site — Fukuoka, Japan (Recruiting)
- Ferring Investigational Site — Hiroshima, Japan (Recruiting)
- Ferring Investigational Site — Hiroshima, Japan (Recruiting)
- Ferring Investigational Site — Hokkaido, Japan (Recruiting)
- Ferring Investigational Site — Hyōgo, Japan (Recruiting)
- Ferring Investigational Site — Osaka, Japan (Recruiting)
- Ferring Investigational Site — Osaka, Japan (Recruiting)
- Ferring Investigational Site — Saitama, Japan (Recruiting)
- Ferring Investigational Site — Tokyo, Japan (Recruiting)
- Ferring Investigational Site — Busan, Korea, Republic of (Recruiting)
- Ferring Investigational Site — Taichung City, Taiwan (Recruiting)
- Ferring Investigational Site — Taipei, Taiwan (Recruiting)
- Ferring Investigational Site — Taipei, Taiwan (Recruiting)
- Ferring Investigational Site — Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Global Clinical Compliance
- Email: Disclosure@ferring.com
- Phone: 862-286-5200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.