Comparative prospective study on the clinical utility of G-banding and next-generation sequencing for chromosomal analysis of products of conception under Advanced Medical Care A in Japan

日本先进医疗A计划下,G显带和二代测序在妊娠产物染色体分析中的临床应用价值比较前瞻性研究

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Abstract

PURPOSE: To compare the clinical utility of G-banding and next-generation sequencing (NGS) for chromosomal analysis of products of conception (POC), a crucial tool for detecting fetal chromosomal abnormalities which are major causes of miscarriage and stillbirth. METHODS: We evaluated the clinical utility of both techniques in a prospective analysis of 40 patients who experienced miscarriages or stillbirths between 6 and 36 weeks of gestation under Advanced Medical Care A in Japan. Both methods were applied to the same POC samples. The primary outcome was the proportion of patients with a presumed cause of miscarriage or stillbirth among all submitted samples. RESULTS: NGS presumed the cause in 75.0% (30/40) of cases, significantly outperforming G-banding's 42.5% (17/40) (p < 0.01). G-banding could analyze 67.5% (27/40) of the samples owing to culture failure, whereas NGS successfully analyzed all samples (100%, 40/40) (p < 0.01). Among the successfully analyzed samples, NGS presumed the cause in 70.3% (19/27) of cases, compared with 62.9% (17/27) for G-banding (p = 0.31). For miscarriages before 12 weeks, NGS presumed the cause in 73.5% (25/34) of cases, significantly higher than the 44.1% (15/34) (p < 0.01) presumed using G-banding. CONCLUSIONS: These results highlight the superior efficacy of NGS over G-banding for presuming causes of miscarriage or stillbirth.

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