To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice
Launched by FERRING PHARMACEUTICALS · Jun 17, 2025
Trial Information
Current as of July 25, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how well a medication called REKOVELLE works and how safe it is for Chinese women undergoing fertility treatments like in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). These treatments help women who have trouble getting pregnant by helping their ovaries produce eggs. The study will observe about 2,500 women across 30 to 50 medical centers in China over nearly three years, to see how REKOVELLE is used in everyday medical practice.
Women who are at least 20 years old, have never used REKOVELLE before, and are about to start an IVF or ICSI cycle with this medication may be eligible to join. Participants will be closely followed to understand how REKOVELLE affects their treatment and any side effects they might experience. Women who have had more than one previous ovarian stimulation cycle, are part of other drug studies, or are using fertility treatments for egg donation or preservation won’t be able to join. The trial aims to provide real-world information to help doctors and patients make better decisions about fertility care.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- * Women who meet all the following criteria are eligible for participation:
- • At least 20 years of age (including the 20th birthday) when signing informed consent
- • Prescribed REKOVELLE for the first time in controlled ovarian stimulation for in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycles
- • Willing and able to provide written informed consent
- Exclusion Criteria:
- * Women who meet any of the following criteria are not eligible for participation:
- • Previously undergone more than 1 controlled ovarian stimulation cycles for IVF or ICSI
- • Currently participating in an interventional clinical study for which treatment with medication is mandated
- • Currently undergoing ovarian stimulation for fertility preservation or oocytes donation
- • Contraindications for the use of REKOVELLE
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a global biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies that address unmet medical needs in various therapeutic areas, including reproductive health, urology, and gastrointestinal disorders. With a strong commitment to advancing healthcare through scientific excellence and patient-centered solutions, Ferring leverages its extensive expertise in hormone-related treatments and personalized medicine. The company actively engages in clinical research to develop safe and effective therapies, striving to improve the quality of life for patients worldwide while maintaining a focus on ethical practices and collaboration in the healthcare community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Global Clinical Compliance
Study Director
Ferring Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported