Introduction
Infertility affects approximately 15% of couples globally, with assisted reproductive technologies (ARTs) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) offering hope. The development of recombinant human follicle-stimulating hormone (rhFSH) has been a cornerstone in ART, yet its short half-life necessitates frequent injections, posing challenges for patient compliance and comfort.
The Innovation: rhFSH-CTP
rhFSH-CTP, a novel long-acting FSH agent, has been developed to address these challenges. By fusing a 28-amino acid carboxyl-terminal peptide sequence to the FSH beta subunit, rhFSH-CTP significantly extends the hormone's half-life, allowing for a single administration to maintain therapeutic levels throughout a reproductive cycle.
Clinical Trial Overview
A multicenter, randomized, positive-controlled phase III clinical trial was conducted across 13 Reproductive Medical Centers in China to evaluate the efficacy and safety of rhFSH-CTP. The trial involved 283 women undergoing IVF or ICSI, randomized into rhFSH-CTP and rhFSH groups.
Key Findings
- Efficacy: The rhFSH-CTP group yielded a mean of 14.6 oocytes, compared to 11.7 in the rhFSH group, indicating non-inferiority in ovarian stimulation.
- Safety: Adverse events were comparable between groups, with no significant differences in treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), or serious adverse events (SAEs).
- Patient Compliance: The single administration of rhFSH-CTP significantly reduces the injection burden, enhancing patient comfort and compliance.
Conclusion
rhFSH-CTP represents a significant advancement in infertility treatment, offering a simplified, effective, and patient-friendly approach to ovarian stimulation. Its development and successful clinical trials underscore the potential for improved outcomes in assisted reproductive technologies, with ongoing research aimed at further validating its benefits and exploring its application across diverse patient populations.
