High variability in results of semen analysis in andrology laboratories in Tuscany (Italy): the experience of an external quality control (EQC) programme

Abstract

SUMMARYWe report the results of the first three trials of an external quality control (EQC) programme performed in 71 laboratories executing semen analysis in Tuscany Region (Italy). At the end of the second trial, participants were invited to attend a teaching course illustrating and inviting to adhere to procedures recommended by WHO (V edition). Results of the first three trials of the EQC documented a huge variability in the procedures and the results. The highest variability was found for morphology (CV above 80% for all the trials), followed by count (CV of about 60% for all the trials) and motility (CV below 30% for all the trials). When results of sperm count and morphology were divided according to the used method, mean CV values did not show significant differences. CV for morphology dropped significantly at the third trial for most methods, indicating the usefulness of the teaching course for morphology assessment. Conversely, no differences were observed after the course for motility and for most methods to evaluate count, although CV values were lower at the second and third trial for the laboratories using the Burker cytometer. When results were divided according to tertiles of activity, the lowest mean bias values (difference between each laboratory result and the median value of the results) for count and morphology were observed for laboratories in the third tertile (performing over 200 semen analysis/year). Of interest, mean bias values for concentration dropped significantly at the third trial for low activity laboratories. In conclusion, lack of agreement of results of semen analysis in Tuscany is mainly because of the activity and the experience of the laboratory. Our study points out the importance of participating in EQC programmes and periodical teaching courses as well as the use of WHO recommended standardized procedures to increase precision and to allow the use of WHO reference values.

Double-blind prospective study comparing two automated sperm analyzers versus manual semen assessment

“…A wide inter-lab variation in concentration and percent normal morphology was found in the reports. However, it is possible to achieve good interlaboratory agreement in semen analysis, provided the technicians undergo regular training and participate in an ongoing program of external quality and internal quality control [5,6]. Recently, the World Health Organization published the 5th edition manual for sperm analysis (WHO 5th Edition) [7].…”

DNA fragmentation in brighter sperm predicts male fertility independently from age and semen parameters

“…However, whether or not semen analysis predicts natural conception is still controversial (3)(4)(5). The predictive power of standard semen parameters is further complicated by the high technical (intra-and interassay [6,7]) and biologic (intra-individual [8,9]) variability of the measurements of semen parameters. In such a situation, identifying other diagnostic tests to use in conjunction with, or in alternative to, semen analysis in the evaluation of infertile men has become an urgent issue.…”

Morfología espermática: comparación de las observaciones realizadas por 10 expertos

“…Como otros autores lo han reportado, la morfología espermática es uno de los parámetros seminales más subjetivos (26), por tal motivo los coeficientes de variación en la mayoría de los estudios son muy altos (24,26,27). Keel et al, reportó variación en la morfología normal de 7 a 56%, en este estudio se reporta, 42.3%, porcentaje que es alto pero no se sale de lo previamente reportado (24).…”

“…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.…”