High variability in results of semen analysis in andrology laboratories in Tuscany (Italy): the experience of an external quality control (EQC) programme
Open accessAbstract
Summary: We 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.
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Filimberti et al. found that the PNS CV was 88.6% despite targeted training in the WHO5 methods.
“Similarly, Filimberti et al. (25) analyzed the outcomes of 56 Tuscan laboratories that participated in a dedicated training program in the WHO5 methods and found that the PNS CV was 88.6% despite targeted training.”
From Poor reproducibility of percentage of normally shaped sperm using the World Health Organization Fifth Edition strict grading criteria (2022) · cites this paper as Filimberti et al. [25]
The Sperm morphology section (Fig. 5, p. 405) reports an overall third-trial morphology CV of 88.62%, consistent with 88.6% for PNS. Materials and Methods reports that 56 laboratories returned third-trial results and that participants were invited to a WHO fifth-edition teaching course after the second trial. It does not establish that all 56 laboratories attended the course, as the citing sentence states. (LLM, conf=0.87)
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Research works printed but not linked: 6
- Rowe PJ, Comhaire FH, Hargreave TB & Mahmoud AMA. (2000) WHO Manual for the Standardized Investigation, Diagnosis and Management of the Infertile Male. Cambridge University Press, Cambridge.
- World Health Organization (1980) WHO Laboratory Manual for the Examination of Human Semen and Semen-Cervical Mucus Interaction, 1st edn. Press Concern, Singapore.
- World Health Organization (1987) WHO Laboratory Manual for the Examination of Human Semen and Semen-Cervical Mucus Interaction, 2nd edn. Cambridge University Press, Cambridge.
- World Health Organization (1992) WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interaction, 3rd edn. Cambridge University Press, Cambridge.
- World Health Organization (1999) WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interaction, 4th edn. Cambridge University Press, Cambridge.
- World Health Organization (2010) WHO Laboratory Manual for the Examination and Processing of Human Semen, 5th edn. World Health Organisation Press, Geneva.
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Barratt, C. L. R., Björndahl, L., De Jonge, C. J., Lamb, D. J., Osorio Martini, F., McLachlan, R., Oates, R. D., van der Poel, S., St John, B., Sigman, M., et al. (2017) · Human Reproduction Update · doi:10.1093/humupd/dmx021 · Cited by 505 · see citing works
Baker, K. C., Steiner, A. Z., Hansen, K. R., Barnhart, K. T., Cedars, M. I., Legro, R. S., Diamond, M. P., Krawetz, S. A., Usadi, R., Baker, V. L., et al. (2022) · F&S Reports · doi:10.1016/j.xfre.2022.03.003 · Cited by 14 · see citing works
“(25) analyzed the outcomes of 56 Tuscan laboratories that participated in a dedicated training program in the WHO5 methods and found that”
Background
- Authors
- Filimberti, E., Degl'Innocenti, S., Borsotti, M., Quercioli, M., Piomboni, P., Natali, I., Fino, M. G., Caglieresi, C., Criscuoli, L., Gandini, L., Biggeri, A., Maggi, M., & Baldi, E.
- Affiliations
- Department of Clinical Physiopathology Sexual Medicine and Andrology Unit Florence Italy
- Azienda Ospedaliero-Universitaria Careggi (IT)
- University of Siena (IT)
- Sterility Center UO Gynecology and Obstetrics Hospital of Pescia Pescia Italy
- University of Pisa (IT)
- University of Florence (IT)
- Sapienza University of Rome (IT)
- Corresponding author
- Maggi, M
- Baldi, E.
- Venue
- Andrology
- Publisher
- Wiley
- Published
- 2013-01-11
- Volume
- 1
- Issue
- 3
- Pages
- 401-407
- ISSN
- 2047-2919 (ISSN-L)
- 2047-2927
- OpenAlex
- W1522795857
- Cited by
- 68
- References
- 0
- Citations by year
- 2026: 5 · 2025: 2 · 2024: 9 · 2023: 5 · 2022: 10 · 2021: 6 · 2020: 4 · 2019: 7 · 2018: 3 · 2017: 3 · 2016: 4 · 2015: 4 · 2014: 3 · 2013: 3
- FWCI
- 2.90
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Andrology (publishedVersion)
- PubMed (publishedVersion)
- Florence Research (University of Florence) (submittedVersion, other-oa)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Use Siena air (University of Siena) (submittedVersion)
- Padua Research Archive (University of Padova) (submittedVersion, other-oa)
- Funders
- Regione Toscana
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Reproductive Medicine › Sperm and Testicular Function
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
- Keywords
- semen analysis, external quality control, inter-laboratory variability, sperm morphology, sperm count, sperm motility, Tuscany
- MeSH terms
- Humans, Italy, Laboratories, Male, Quality Control, Semen, Sperm Motility, Andrology
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