SPERM CHROMATIN DISPERSION TEST FOR EXAMINATION OF INFERTILE MALE: FROM СLINICAL TRIALS OF FIRST RUSSIAN KIT GEMSTANDART–HALOSPERM L&Q

Objectives. To evaluate the sperm chromatin dispersion in men with infertility using the first Russian kit. Methods. The study was conducted between July and August 2022. Study participants were 492 male volunteers aged 23 to 59 years with infertility which semen samples were examined by GEMSTANDART–HaloSperm L&Q kit so-called Halo test. The outcomes were as a percentage as the sperm DNA Fragmentation Index (DFI), %. The results of Halo test were evaluated according to the following threshold values: in reference range (normal): DFI  15 %, controversial result: from DFI > 15 % to < 25 %, out of reference range (pathological) DFI > 25 %. All of men (n = 492) had the results of a basic semen examination which performed a month before the current clinical trials with a various scenario of pathospermia as well as normospermia. The statistical processed a GraphPad Prism software (version 8.0.1) and Excel statistical package Microsoft® Excel® for Microsoft 365 MSO (verse 2201 16.0.14827.20158). The Pearson’s rank correlation coefficient of parametric measure and descriptive statistics have been applied. Results. Sperm DNA fragmentation (SDF) was not detected in 54.1 % (266/492 = 54.1 %) men whose average age was 36.58 years (DFI  15 %); a poor direct correlation with normal level of DFI and asthenozoospermia (r = 0.20; p < 0.0001), viscosipathy (r = 0.13; p < 0.0001) are presented; a poor inverse correlation with oligoasthenoteratozoospermia (r = – 0.12; p < 0.0001) are presented; the absence of leucospermia was noted. A controversial results for SDF presence was found in 21.3 % (105/492 = 21.3 %) men whose average age was 38.71 years (DFI range from > 15 to < 25 %); a poor direct correlation with oligoasthenoteratozoospermia (r = 0.24; p < 0.0001), oligospermia (r = 0.23; p < 0.0001) and average age of 39 years (r = 0.17; p < 0.0001) was noted; poor inverse correlation with asthenozoospermia (r = – 0.22; p < 0.0001) was presented. SDF was found in 24.6 % (121/492 = 24.6 %) men whose average age was 41.55 (DFI > 25 %); poor direct correlation with a high level of DFI and average age for infertile men in 44 years (r = 0.28; p < 0.0001) was presented. All semen samples (n = 492) presented a poor positive correlation with DFI and age (r = 0.1563; p = 0.0005); oliasthenoterato-zoospermia (r = 0.19; p = 0.0001), leucospemia (r = 0.29; p = 0.0001), and necrozoospermia (r = 0.16; p = 0.0004). Conclusion. The results of the study showed that GEMSTANDART–HaloSperm L&Q kit complements a basic semen examination providing specific information to the clinicians about quality of genetic material in semen samples.