Sdad assay and uses thereof

Abstract

Methods for screening human sperm using a sperm DNA accelerated decondensation (SDAD) Test, readable at a 5 minute time point, are disclosed. The method is useful in the screening and clinical management for a reproductively challenged human couple. The methods disclosed are highly predictive of ICSI outcome. Methods for screening human sperm using a sperm DNA decondensation (SDD) Test, readable at a 15 minute time point, are disclosed. This test is highly predictive of IUI and IVF outcome. Also dislosed are methods for selecting an appropriate assisted reproductive technique (ART) for a reproductively challenged couple. These methods provide a decision tree that employs a patient's sperm test results in a sperm DNA accelerated decondensation (SDAD) Test, and sperm DNA decondensation (SDD) Test, wherein an appropriate assisted technique may be selected from intrauterine insemination (IUI), IVF or ICSI. Also, methods are described that will identify males who may benefit from anti-oxidant therapy and/or a varicocelectomy before using their sperm in ART. An automated scoring method is also disclosed for assessing sperm activity after a 5-minute incubation in egg extract (SDAD Test), and after a 15-minute incubation in egg extract (SDD Test). Finally, an automated sperm processing protocol is also disclosed for the rapid preparation of sperm for analysis in both the SDD and SDAD Tests.

1 . A sperm DNA accelerated decondensation test capable of assessing male fertility comprising:
 monitoring test sperm decondensation in a frog egg extract for a period of 5 minutes to 10 minutes,   wherein a quantifiable difference between a test sperm decondensation and a known fertile male sperm decondensation after a period of 5 to 10 minutes provides an assessment of male fertility.   
   
   
       2 . The method of  claim 1 , wherein the frog egg extract is a  Xenopus  laevies frog egg extract.