Research Project
6337121
DESCRIPTION (Scanned from the applicant's description): Cryopreserved human sperm are essential for important therapies. With standard procedures, post-thaw quality of samples from many/most patients (donors are highly selected) is unacceptable, 40 percent of the sperm are damaged, and pregnancy rate is low. Biology to improve outcome is available, but unused because of limited efforts to adapt knowledge to an approach practical in a clinical setting. This project is focused on that goal and will use containers with "gated-pore" faces and a "rapid cryoprotectant removal device" (RCRD) to eliminate post-thaw damage to human sperm resulting from rapid movement of water into the cells. Their use allows cryopreservation of sperm within a sealed container, and post-thaw opening of the gated pores and, at a rate safe for the sperm, replacement of cryo-extender with a buffer appropriate for intrauterine insemination (IUI) and not irritating to tissues--automatically and safely (for sperm and operator) without dilution or removal of sperm from the container until IUI. Phase-I demonstrated feasibility. Phase-II objectives are: (1) refine the CryoCell container and RCRD to meet standards needed for clinical trials and optimize thaw rate; (2) compare results with the new technology and standard procedures; and (3) evolve and validate procedures appropriate for clinical trials. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE
