External quality control program for semen analysis: Spanish experience

Abstract

Purpose : Results from an external quality control programme for semen analysis carried out in Spain are analysed. Methods : Quality control materials were distributed and the following seminal parameters were determined: concentration, total motility, progressive motility, rapid progressive motility, morphology and sperm vitality. The between-laboratories coefficients of variation were assessed on different types of quality control material. Results : The majority of participating laboratories utilised manual versus computer-assisted semen analysis methods. Some between-laboratories coefficients of variation ranges were: 20.8-33.8% for concentration (semen pool suspension); 13.9-19.2% for total motility (videotapes); 54.2-70.2% for sperm morphology (strict criteria using stained smears); and 9.8-41.1% for sperm vitality (stained smears). There was an inverse relation between mean percentage of sperm and coefficients of variation between laboratories for sperm motility, morphology and vitality. Conclusions : These data highlight the urgent need for improvement in the overall quality of andrology testing.

Clinical relevance of routine semen analysis and controversies surrounding the 2010 World Health Organization criteria for semen examination

“…In the aforementioned study, participating laboratories had high inter--observer variability when evaluating the same specimen. These data were corroborated by another study in which interlaboratory coefficient of variation was as high as 34% for sperm concentration, 20% for total sperm motility, 40% for sperm vitality, and 70% for sperm morphology (strict criteria) (39). Discrepancies were also seen in laboratories enrolled in quality control programs, thus indicating that there is a need of global standardization among the laboratories and the providers of external quality control (40).…”

Morfología espermática: comparación de las observaciones realizadas por 10 expertos

“…Lo anterior es también observado al comprar el resultado final en porcentaje de la totalidad de morfología normal y anormal para el total de los espermatozides analizados, se observó un 73.8% de variación en la morfología normal y solo 4.5% en la morfología anormal (Figura 1). Además de recalcar la importancia de realizar estandarización entre los laboratorios con el fin de disminuir los coeficientes de variación interlaboratorio y repercutir positivamente en un mejor resultado para el paciente y por lo tanto en un mejor diagnóstico, este estudio permite plantear la necesidad de crear un sistema de estandarización nacional, usando placas coloreadas en lugar de imágenes, incluyendo un numero mayor de centros y laboratorios (clínicos, investigativos y académicos) en los cuales se determine la calidad seminal y reuniones periódicas con el fin de socializar las metodologías propuestas por la OMS (26)(27)(28)(29)(30). Finalmente, estos resultados cobran mayor relevancia en el marco de un proyecto de ley en la Cámara de Representantes (Ley Sara) el cual posiblemente permitirá que muchas parejas accedan a tratamientos de reproducción asistida en los cuales seguramente el espermograma será una examen de rutina, por lo cual es de suma importancia mejorar la técnica y estandarizar a todos los laboratorios y expertos en la evaluación seminal.…”

A systematic review of recent clinical practice guidelines and best practice statements for the evaluation of the infertile male

“…These guidelines recommend that laboratories should comply with high-quality standards as defined by either the WHO [16] or the Clinical Laboratory Improvement Amendments (CLIA) [34]. This is an important aspect since data from surveys of laboratory practice in the USA and the UK revealed that semen analysis techniques are still poorly standardized, indicating that there is a need of global standardization among the laboratories and the providers of external quality control [35][36][37][38]. Clinicians generally rely on the values provided by the laboratory to direct further work-up, diagnose, counsel and manage infertile males.…”