title: Redefining the relationship between sperm deoxyribonucleic acid fragmentation as measured by the sperm chromatin structure assay and outcomes of assisted reproductive techniques.
abstract: OBJECTIVE
  To test the hypothesis that couples with sperm chromatin structure assay (SCSA) DNA fragmentation index (DFI) values >27% would not achieve pregnancy with assisted reproductive techniques (ART) and to investigate how DFI and high DNA stainability (HDS), as measured by the SCSA, affect fertilization, cleavage, implantation, and pregnancy rates in IVF cycles.
  
  
  METHODS
  Prospective clinical study.
  
  
  METHODS
  Academic human reproduction laboratory.
  
  
  METHODS
  One hundred couples undergoing IVF with conventional insemination or intracytoplasmic sperm injection.
  
  
  METHODS
  Testing with SCSA was performed by SCSA Diagnostics (Brookings, South Dakota) on a semen aliquot taken from ejaculate used for ART.
  
  
  METHODS
  Relating total DFI and HDS to conventional semen parameters and cycle-specific outcomes after ART.
  
  
  RESULTS
  Nine of nineteen couples achieved clinical pregnancy when DFI was > or =27%, and 2 of 22 couples achieved clinical pregnancy when DFI was < or =9%. One of nine couples achieved clinical pregnancy with HDS >17%. The DFI was negatively correlated with sperm density (r = -0.23, P<.03) and motility (r = -0.55, P<.00), and HDS was negatively correlated with sperm density (r = -0.37, P<.00).
  
  
  CONCLUSIONS
  Sperm chromatin structure assay failed to identify elevated DFI thresholds for negative pregnancy outcome after ART. Patients with low DFI (< or =9%) were least likely to become pregnant, which is also contradictory to SCSA marketing, which states that DFIs of < or =15% have excellent fertility potential. Patients with HDS > or =17% had low pregnancy rates, indicating decreased fertility potential, which deserves further investigation. Larger studies are necessary to confirm that low DFI is associated with decreased fertility and, if proved, might redefine the use of the SCSA in evaluating infertility.
authors.affiliation: Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina 27710, USA.
authors.forename: John F
authors.initials: JF
authors.lastname: Payne
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Raburn
authors.forename: Grace M
authors.initials: GM
authors.lastname: Couchman
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Price
authors.forename: Margaret G
authors.initials: MG
authors.lastname: Jamison
authors.forename: David K
authors.initials: DK
authors.lastname: Walmer
mesh_terms: D000328:Adult; D002843:Chromatin / Q000502:physiology*; D053938:DNA Fragmentation / Q000502:physiology*; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D011247:Pregnancy; D011446:Prospective Studies; D027724:Reproductive Techniques, Assisted; D013081:Sperm Motility / Q000502:physiology*; D013094:Spermatozoa / Q000502:physiology*
chemical_list: D002843:Chromatin