Pioneering FDA-Cleared At-Home Intravaginal Insemination for Enhanced Fertility Care
IVF.net Newsdesk03 January 2024
Mosie Baby, an innovative fertility care provider, recently achieved a significant milestone by obtaining FDA Class II clearance for its at-home intravaginal insemination (IVI) kit. This marks a groundbreaking advancement as the first over-the-counter, FDA-cleared kit designed for IVI, creating new opportunities for patient care in the realm of fertility treatments.
Clinical Implications and Design Designed for use with fresh or cryogenically frozen donor semen, the Mosie Baby Kit includes two uniquely designed syringes and semen collection cups. The syringes feature a patented, barrel-free tip and slit opening, enhancing semen transfer efficiency while minimizing waste. The collection cups, with a proprietary design, optimize semen collection. This kit underwent rigorous clinical and technical testing, including Human Sperm Survival Assay, to ensure non-toxicity, non-irritation, non-sensitization, and freedom from microbial contamination. The kit's design and testing underscore its suitability for at-home use while aligning with clinical standards.
Physician Perspective For physicians, the Mosie Baby Kit presents an option for patients facing infertility challenges or those for whom traditional intercourse is not feasible or preferred. The kit's FDA clearance and adherence to high testing standards provide medical professionals confidence in recommending it as a viable at-home fertility solution. It enables physicians to extend fertility care beyond the clinic, offering a cost-effective, accessible, and user-friendly alternative to in-office procedures. By providing an FDA-reviewed option for at-home insemination, Mosie Baby empowers individuals and couples in their fertility journey, offering them a sense of autonomy and privacy in the process.