Method and pharmacological composition for the diagnosis and treatment of male

A pharmaceutical composition for use in the treatment of male sub-fertility comprising:

• an active ingredient selected from the group consisting of:
• a deoxyribonuclease (DNase), a substance that blocks the interaction between cell free DNA and sperm cell surface receptors, a substance that binds to DNA, a substance that inhibits endogenous sperm cell Dnase, a substance that inhibits a member of a signal transduction pathway mediated by DNA binding to sperm cell surface receptors, an agent that stimulates production of an endogenous substance that causes a reduction in an antifertility effect of cell free DNA on sperm cells, an agent that causes a reduction in an effect of extracellular DNA on sperm cells, and an agent that stimulates production of an endogenous substance that causes a reduction in an effect of extracellular DNA on sperm cells;
• and
• a physiologically acceptable carrier.

A method for determining a fertility status in a male subject, comprising:

• obtaining from the subject a sample of a body tissue or fluid;
• measuring in the sample a cell-free DNA level or a level of an agent that causes a reduction in the effect of cell-free DNA on sperm cells;
• comparing the measured level to one or more predetermined threshold values;
• and
• determining the fertility status based upon the comparison.

A method for determining a fertility status in a male subject, comprising:

• obtaining from the subject a sample containing sperm cells;
• measuring in the sperm cells a level of a substance indicative of apoptosis;
• comparing the measured level to one or more predetermined threshold values;
• and
• determining the fertility status based upon the comparison.