The study will involve up to 20 investigational sites to start screening of about 140 male subjects aged between 20 and 60 years. Enrolled patients will undergo treatment over a four-week period.
Currently, infertility affects an estimated 15-25% of couples globally. Male infertility can be caused by various problems, including stress, uncontrolled use of drugs, increase of radiation background, diseases of male sexual system, injuries and many other factors. Male infertility is usually characterized by a low total sperm count in ejaculate and/or low sperm motility. To date, no medical treatment has been proven to be sufficiently effective for male infertility.
In this project, OCT will be responsible for site selection, monitoring activities, preparation and maintenance of investigator site file, as well as safety issues.