Laboratory and Clinical Medicine. Pharmacy

Scientific and practical quarterly peer-reviewed journal

ISSN 2712-9330 (Online)

  • Continuous numbering: 21
  • Pages: 36-44
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Heading: New Look from Clinical and Pharmaceutical Practice

The diagnosis of male infertility remains a complex cross-disciplinary challenge requiring the integration of laboratory, instrumental, and clinical approaches. This study aimed to develop and model a digital diagnostic platform for the comprehensive assessment of ejaculate quality, ensuring improved reproducibility and clinical informativeness of laboratory tests in male fertility evaluation. We propose a digital platform integrating three key components: a microfluidic diagnostic chip (MDC) for automated samples fractionation; an artificial intelligence (AI) module for standardized interpretation of cytological preparations (sperm sediment cytology, SSC); and a cloud-based module for digital slide storage and patient routing. The developed digital platform can provide a technological foundation for standardized, reproducible, and clinically oriented diagnostics of male infertility, consistent with the principles of lean technologies and information security requirements. The proposed solution enables the reduction of diagnostic losses, minimization of interpretation subjectivity, and provision of personalized patient routing at all stages of laboratory evaluation.
Zhanna Yu. Sapozhkova – MD, PhD; Academic Director at the International Cytology School & Innovatory Medical School; Head of the Cytology Laboratory, Clinical Laboratory Diagnostics Physician at the Moscow Regional Oncological Clinical Center, Moscow, Russia.
1. Davidova ZY, Chelikova GA. The role of an interdisciplinary approach in the search for effective diagnostic algorithms in the laboratory examination of patients with diseases of the male accessory sex glands. Laboratornaya i klinicheskaya meditsina. Farmatsiya. 2024;4(1):17-24. DOI: 10.14489/lcmp.2024.01.pp.017-024. (in Russ).
2. Davidova ZY. Method for assessing male reproductive function. Patent RF No.2819094. May 14, 2024. Bul. No.14. (in Russ).
3. Sapozhkova ZY, Dolgov VV. A novel laboratory algorithm for the comprehensive analysis of ejaculate (Part 1). Laboratornaya i klinicheskaya meditsina. Farmatsiya. 2025;5(3):15-22. DOI: 10.14489/lcmp.2025.03.pp.015-022. (in Russ).
4. Sapozhkova ZY, Dolgov VV. Validation of the novel laboratory algorithm for comprehensive ejaculate analysis: a case series (Part 2). Laboratornaya i klinicheskaya meditsina. Farmatsiya. 2025;5(3):47-54. DOI: 10.14489/lcmp.2025.03.pp.047-054. (in Russ).
5. Sapozhkova ZY. Method for microscopic assessment of sperm quality following ejaculate sedimentation. Patent RF No.2686685. November 19, 2021. Bul. No.32. (in Russ).
6. Davidova ZY, Chelikova GA. Cytological examination of the ejaculate sediment in the diagnosis of reproductive disorders. Laboratornaya sluzhba. 2023;12(4):3-56. (in Russ).
7. Sapozhkova ZY, Milovanova GA, Pochernikov DG, et al. Diagnostic potential of ejaculate sediment analysis using real-time PCR amplification and microbiological examination in identifying causes of male reproductive dysfunction. Meditsinskie tekhnologii. Otsenka i vybor. 2022;44(2):62-71. (in Russ).
8. Pochernikov DG, Postovoytenko NT, Davidova ZY. Effectiveness of preanalytical PCR modifications for the detection of latent urogenital infections in men. Laboratornaya i klinicheskaya meditsina. Farmatsiya. 2023;3(2):4-11. DOI: 10.14489/lcmp.2023.02.pp.004-011. (in Russ).
9. Sapozhkova ZY, Pochernikov DG, Galkina IS. The role of ejaculate sediment cytology and PCR diagnostics in the search for possible causes of male infertility and early oncopathology. Akusherstvo i ginekologiya. 2019;(4 Suppl):75-6. (in Russ).
10. Pochernikov DG, Postovoytenko NT, Strelnikov AI. Comparative analysis of cultural and molecular-genetic methods in the study of ejaculate microbiota in male infertility. Andrologiya i genitalnaya khirurgiya. 2019;20(2):40-7. (in Russ).
11. Sapozhkova ZY, Dolgov VV. Diagnostic value of cytological examination of the ejaculate sediment for the detection of human papillomavirus. Klin Lab Diagn. 2026;71(1):97-104. DOI: 10.51620/0869-2084-2026-71-1-97-104. (in Russ).
12. Sapozhkova ZY. Laboratory method for evaluating male reproductive function based on sperm DNA fragmentation. Patent RF No.2795567. May 5, 2023. Bul. No.13. (in Russ).
13. Sapozhkova ZY, Dolgov VV. Clinical and laboratory assessment of the association between DNA fragmentation index and semen parameters in men of different age groups. Klin Lab Diagn. 2025;70(11):776-83. DOI: 10.51620/0869-2084-2025-70-11-776-783. (in Russ).
14. Davidova ZY. A method for assessing reactive oxygen species in male infertility diagnosis. Patent RF No.2831319. December 4, 2024. Bul. No.34. (in Russ).
15. Sapozhkova ZY, Dolgov VV. Clinical and laboratory evaluation of the relationship between ejaculate parameters, reactive oxygen species levels and age in subfertile men. Laboratornaya i klinicheskaya meditsina. Farmatsiya. 2025;5(2):24-32. DOI: 10.14489/lcmp.2025.02.pp.024-032. (in Russ).
16. Sapozhkova ZY. Basic and advanced ejaculate parameters in infertile patients: cytology of the ejaculate sediment, sperm DNA fragmentation and reactive oxygen species in normozoospermia and viscosipathy. Clinical observations. Laboratornaya i klinicheskaya meditsina. Farmatsiya. 2024;4(3):24-30. DOI: 10.14489/lcmp.2024.03.pp.024-030. (in Russ).
17. Sapozhkova ZY, Supryago MA. Systematization of cytological changes in the ejaculate sediment: a catalogue and clinical significance. Laboratornaya i klinicheskaya meditsina. Farmatsiya. 2026;6(2):57-72. DOI: 10.14489/lcmp.2026.02.pp.057-072. (in Russ).
18. Kasoyan KT, Shabalova IP, Sapozhkov VA, et al. A review of the Pathoview service for the exchange of digital microscopic slides. Laboratornaya i klinicheskaya meditsina. Farmatsiya. 2023;3(1):4-10. DOI: 10.14489/lcmp.2023.01.pp.004-010. (in Russ).
19. On Personal Data: Federal Law No.152-FZ of 27.07.2006 (as amended on 24.06.2025). Sobranie zakonodatelstva RF. 2006;31(pt 1):Art. 3451. (in Russ).

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Sapozhkova ZhYu. Modelling of a digital diagnostic platform for semen quality assessment. Laboratory and Clinical Medicine. Pharmacy. 2026;6(3):36-44. (In Russ). DOI: 10.14489/lcmp.2026.03.pp.036-044