ArticleF&S reports2024
Validation of a mail-in delayed semen analysis protocol developed for home collection.
Article in F&S reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
5 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Objective: To validate a mail-in delayed semen analysis service using deidentified remnant samples from a US fertility clinic. Design: Double-blinded prospective validation of screening/diagnostic test. Setting: Fertility clinic and clinical reference laboratory. Patients: Deidentified remnant samples from patients attending fertility clinic for fertility assessment (study A, n = 68; study B, n = 232). Interventions: None. Main Outcome Measures: Total motility, concentration, and morphology (Kruger, strict) measures were compared between split semen specimens that underwent comprehensive semen analysis at <1 hour (referent) and 26 hours (experimental). The concordance between the paired measures was described using coefficient of variance and percent bias. Clinical concordance (CC) between 1- and 26-hour results for total motility, concentration, and morphology measures was also reported, using the fifth centile clinical reference ranges described in the World Health Organization manual (fifth edition). Results: In a controlled laboratory setting (study A), total motility, concentration, and morphology measures were highly consistent between the 1- and 26-hour analyses, with mean coefficients of variation (%CVs) of 9.0% for total motility, 4.0% for concentration, and 3.0% for morphology. There were also high CC rates: 94.2% for total motility; 100% for concentration; and 98.5% for morphology. In a real-world setting (study B), which included commercial shipment of specimens, the mean %CVs for total motility and concentration were 15% and 27%, respectively, which were more variable than those in study A yet still considerably less variable than that measured between laboratories using College of Anatomical Pathologist proficiency testing during the study period (motility %CV, 31%; concentration %CV, 37%). These comparisons also had high CC rates for total motility (86%) and concentration (93.1%). Conclusions: These results demonstrate the validation of a laboratory service that provides accurate, comprehensive semen analysis on specimens collected remotely and shipped overnight to a clinical diagnostic laboratory.
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