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Development and integration of LensHooke® R10 for automatic and standardized diagnosis for sperm DNA fragmentation.
Hsu, Cheng-Teng; Lee, Chun-I; Huang, Chun-Chia; Wang, Tse-En; Chang, Hui-Chen; Chang, Li-Sheng; Lee, Maw-Sheng.
Afiliação
  • Hsu CT; Center for Research and Development, Bonraybio Co., Ltd., Taichung, Taiwan.
  • Lee CI; Division of Infertility Clinic, Lee Women's Hospital, Taichung, Taiwan.
  • Huang CC; Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.
  • Wang TE; Department of Obstetrics and Gynecology, Chung Shan Medical University, Taichung, Taiwan.
  • Chang HC; Division of Infertility Clinic, Lee Women's Hospital, Taichung, Taiwan.
  • Chang LS; Center for Research and Development, Bonraybio Co., Ltd., Taichung, Taiwan.
  • Lee MS; Center for Research and Development, Bonraybio Co., Ltd., Taichung, Taiwan.
Andrology ; 11(7): 1337-1344, 2023 10.
Article em En | MEDLINE | ID: mdl-36869577
BACKGROUND: The sperm chromatin dispersion assay is commonly used to assess sperm DNA integrity. This approach is time-consuming, demonstrates poor chromatin preservation, and provides an ambiguous and unstandardized evaluation of fragmented chromatin. OBJECTIVES: We aimed to (i) develop an optimized sperm chromatin dispersion assay with reduced operation time, (ii) validate R10 test accuracy by comparing it to a conventional sperm chromatin dispersion assay, and (iii) standardize the sperm DNA fragmentation analysis procedure by integrating artificial intelligence optical microscopic technology. MATERIALS AND METHODS: This cross-section study included 620 semen samples. Aliquots were analyzed by a conventional Halosperm® G2 assay (G2) and LensHooke® R10 assay (R10). The DNA fragmentation index was scored manually, and R10 slides were automatically determined by a LensHooke® X12 PRO semen analysis system (X12). RESULTS: We demonstrated significant improvements in total assay time (40 vs. 72 min, p < 0.001) and in the halo-cytological resolution using R10 compared to G2. Comparing the G2 and R10, DNA fragmentation index results demonstrated good agreement between the two methods (Spearman's rank correlation, rho = 0.8517, p < 0.0001). We introduced the integration of an auto-calculation system to diagnose sperm DNA fragmentation. X12 interpretation showed excellent agreement with manual interpretation (Spearman's rank correlation, rho = 0.9323, p < 0.0001), but had a low coefficient of variation compared to manual interpretation (4% for R10 by X12 vs. 19% for R10 by manual scoring vs. 25% for G2 by manual scoring). DNA fragmentation index was more correlated with total motility (coefficients = -0.3607, p < 0.0001) than sperm morphology and was positively associated with asthenozoospermic semen samples (p = 0.0001). CONCLUSION: The R10 sperm chromatin dispersion assay combined with the X12 semen analysis system is faster, more objective, and provides standardization for sperm DNA fragmentation.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Sêmen / Infertilidade Masculina Tipo de estudo: Diagnostic_studies / Guideline Limite: Humans / Male Idioma: En Revista: Andrology Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Taiwan

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Sêmen / Infertilidade Masculina Tipo de estudo: Diagnostic_studies / Guideline Limite: Humans / Male Idioma: En Revista: Andrology Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Taiwan