Male reproductive health panel and uses thereof

摘要

A method for assessing male reproductive health is disclosed. In some embodiments, the method comprises screening a sperm sample for sperm DNA accelerated decondensation (SDAD), for sperm DNA fragmentation index (DFI) and/or for delayed sperm DNA decondensation (SDD). The method is useful in the screening and clinical management of reproductively challenged human couples and for assessing reproductive health of potential sperm donors. A method is also provided for selecting an assisted reproductive technology (ART) best suited for a particular donor sperm sample. An automated method for assessing SDAD and SDD test scores is also disclosed, as well as an automated sperm processing protocol for preparing sperm for analysis of SDAD and SDD.

主权项

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.