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About Male Factor Infertility
Male factor infertility is implicated in about half of the 6 million infertile couples in the U.S. Asthenozoospermia, lack of or low sperm motility, is a common cause of human male infertility. It has been reported in the medical literature that the prevalence of asthenozoospermia in infertile men is approximately 82 percent. Currently, there is no FDA-approved product that enhances sperm motility.
Cordex's proprietary ATPotent is being developed as a sperm processing medium to enhance sperm motility in conjunction with in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures. One component of ATPotent is ATP, a naturally occurring biological molecule that is found in all human cells. Naturally occurring ATP in the female reproductive tract is believed to play a facilitating role in normal egg fertilization. Several in vitro studies conducted on sperm of human and other species suggest that ATP treatment of poorly motile sperm resulted in improved motility parameters and increased frequency of hyperactivated sperm.
Results of a study sponsored by Cordex was recently published in the journal of Reproductive Sciences (Scott E. Edwards, et al., "Effects of Extracellular Adenosine 5'-Triphosphate on Human Sperm Motility," 2007; 14: 655-666). The study, conducted by scientists from the Center for Research on Reproduction and Women's Health of the University of Pennsylvania and the Department of Medical and Surgical Sciences of the University of Padova, Italy, showed that ATP treatment of poorly motile human sperm in vitro (outside of the human body) resulted in improved motility parameters and increased frequency of hyperactivated sperm. Furthermore, improved motility parameters were also observed in human sperm derived from males with asthenozoospermia (a disorder characterized by lack of or low sperm motility), and human sperm from cryopreservation.
The authors suggested that these effects of ATP could explain the increased success rate of IVF procedures observed in an earlier non-Cordex sponsored European study, in which ATP-treated sperm derived from infertile males with asthenozoospermia were used.
Cordex believes that the data in this study and other studies strengthen the rationale for the development of ATPotent, which contains ATP, as a novel, sperm motility enhancement medium in conjunction IVF and IUI procedures. Cordex plans a 510(k) FDA medical device approval route and is planning to meet with the FDA to discuss such a regulatory path.
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Human Sperm Illustration courtesy of scientificimages.com
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