Novel sperm chromatin dispersion test with artificial intelligence-aided halo evaluation; A comparison study with existing modalities.

Sperm chromatin dispersion (SCD) test is a common and inexpensive technique to assess sperm DNA fragmentation while its subjectivity with assessing small number of spermatozoa are the disadvantages.

To study the efficacy of a new SCD test kit (R10) combined with an artificial intelligence (AI)-aided halo evaluating platform (X12) and compare the results to existing sperm DNA fragmentation testing methods.

Semen samples from normozoospermic donors (n = 10) and infertile men with abnormal semen parameters (n = 10) were enrolled. DNA fragmentation indices were examined by multiple assays including R10, Halosperm G2® (G2), sperm chromatin structure assay (SCSA), and terminal deoxynucleotidyl transferase deoxynucleotidyl transferase nick end labeling (TUNEL). In R10 assay, the DNA fragmentation indices were obtained both manually (manual R10) and by X12 (AI-R10). The obtained DNA fragmentation indices (DFIs) were analyzed by agreement analyses.

The DFIs obtained by Manual R10 and those obtained by AI-R10 showed a strong significant correlation (r = 0.97, p<0.001) and agreement. The number of spermatozoa evaluated by AI-R10 was 2078 (680-5831). The DFIs obtained by Manual R10 and AI-R10 both correlated with those of G2 (r = 0.90, p<0.001; r = 0.88, p<0.001). Between AI-R10 and G2 results, Passing-Bablok regression showed no systematic or proportional difference and Bland-Altman plots revealed overall agreement and a mean bias of 6.3% with a standard deviation (SD) of 6.9% (95% limit of agreement: -7.2%-19.9%). AI-R10 and SCSA showed systematic difference with a mean bias of -1.9%, while AI-R10 and TUNEL revealed proportional difference with a mean bias of -10.7%.

The novel SCD kit and AI-aided platform demonstrated significant correlation and agreement with existing SCD method, by assessing greater number of spermatozoa. This technique has the potential to provide a rapid and accurate assessment of sperm DNA fragmentation without technical expertise or flow cytometry. This article is protected by copyright. All rights reserved.

Andrology. 2023 Mar 31 [Epub ahead of print]

Shinnosuke Kuroda, Keshab Kumar Karna, Raneen Sawaid Kaiyal, Rossella Cannarella, Scott D Lundy, Sarah C Vij, Ashok Agarwal

Department of Urology, Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Cleveland, OH, USA., Department of Molecular, Cell and Cancer Biology, University of Massachusetts Medical School, Worcester, MA, USA., Global Andrology Forum, American Center for Reproductive Medicine, Moreland Hills, OH, USA.