Patent ID: 9157909
Filing Date: 2015-10-13
Classification: A61D,C12Q,G01N

Abstract:
1. A method for determining if a donor test sperm sample is appropriate for use in an assisted reproductive technology (ART) comprising: (a) assessing sperm DNA accelerated decondensation (SDAD) rate of the test sperm sample and comparing said rate to a control sperm SDAD rate to provide a test sperm SDAD score comprising: incubating the test sperm sample in a non-mammalian egg extract capable of supporting human sperm DNA decondensation and sperm DNA synthesis for a defined incubation period of about 5 minutes; determining a test sperm SDAD percentage from the percent of DNA decondensed in the test sperm sample; and comparing the test sperm SDAD percentage to a control sperm SDAD percentage to provide a test sperm SDAD score, wherein a test sperm SDAD score that is 120% or greater identifies a test sample demonstrating an abnormal test sample SDAD score; and (b) assessing the test sperm, sample to determine a test sperm DNA fragmentation index (DFI) comprising: determining a ratio of broken DNA to unbroken DNA in the test spent1 sample to provide a test sperm DNA fragmentation index (DFI), wherein a test sperm sample having a DFI of 30 or greater-identifies an abnormal test sample DFI and a DFI of less than 30 identifies a normal DFI and (c) assessing the donor test sperm for an appropriate assisted reproductive technology (ART) of intracytoplasmic sperm injection (ICSI), intrauterine insemination (ILA) or IVF-embryo transfer, wherein a donor test sperm demonstrating an SDAD score of 120% or greater (abnormal) and a DFI of greater than 30 (abnormal) is unsuitable as a donor for use in an intracytoplasmic sperm injection (ICSI) procedure, and wherein a donor test sperm having a DFI of less than 30 (normal) and an SDAD that is not greater than 120% (normal) is suitable for use in an assisted reproductive technology of intracytoplasmic sperm injection (ICSI), intrauterine insemination (IUI) or IVF-embryo transfer.