The Andrological Landscape in the Twenty-First Century: Making Sense of the Advances in Male Infertility Management for the Busy Clinicians.

Male infertility represents a significant global problem due to its essential health, social, and economic implications. It is unsurprising that scientific research is very active in this area and that advances in the diagnostic and therapeutic fields are notable. This review presents the main diagnostic advances in male infertility, starting from the changes made in the latest WHO Manual of semen analysis and discussing the more molecular aspects inherent to "omics". Furthermore, the usefulness of artificial intelligence in male infertility diagnostics and the latest advances in varicocele diagnosis will be discussed. In particular, the diagnostic path of male infertility is increasingly moving towards a personalized approach to the search for the specific biomarkers of infertility and the prediction of treatment response. The treatment of male infertility remains empirical in many regards, but despite that, advances have been made to help formulate evidence-based recommendations. Varicocele, the most common correctable cause of male infertility, has been explored for expanded indications for repair. The following expanded indications were discussed: elevated sperm DNA fragmentation, hypogonadism, orchalgia, and the role of varicocele repair in non-obstructive azoospermia. Moving forward with the available data, we discussed the stepwise approach to surgical sperm retrieval techniques and the current measures that have been investigated for optimizing such patients before testicular sperm extraction. Finally, the key points and expert recommendations regarding the best practice for diagnosing and treating men with infertility were summarized to conclude this review.

Improving standard practices in studies using results from basic human semen examination.

The purpose of this article is to provide an explanation of the background behind a checklist that declares the laboratory methods used in a scientific study. It focuses primarily on implementing laboratory procedures to yield reliable results in basic semen examinations. While the World Health Organization (WHO) and international standards provide recommendations for basic semen examination, manuscripts submitted to Andrology frequently lack transparency regarding the specific techniques used. In addition, the terminology used for semen examination results often fails to provide a clear definition of the groups under study. Furthermore, the WHO's reference limits are often misinterpreted as strict boundaries between fertility and infertility. It is important to note that valid clinical andrological diagnoses and treatments cannot rely solely on semen examination results; they require proper laboratory procedures as a foundation for diagnosing and treating male patients. Therefore, scientific journals should promote the adoption of robust laboratory practices and an accurate definition of patient groups. A checklist can facilitate the design of high-quality studies and the creation of informative publications. Further, it can help journals assess submitted manuscripts and improve the overall quality of their publications.

WHO Laboratory Biosafety Manual: A New Approach to Security.

The paper aims to highlight the new indications introduced in the 4th edition of the "Laboratory Biosafety Manual" of World Health Organization. The authors propose a new vision to improve biosafety and biosecurity in the laboratory aligned with the technical standards ISO 35001:2019 "Biorisk management for laboratories and other related organizations" and ISO 45001:2018 "Occupational health and safety management systems-Requirements with guidelines for use" framework. The current edition has a more innovative approach compared to the previous ones, more attention is given to training awareness and providing skills, to promote the culture of safety by adopting an approach based on risk analysis, rather than the prescriptive approach that has been used previously.

The statistical foundation of the reference population for semen analysis included in the sixth edition of the WHO manual: a critical reappraisal of the evidence.

In the most recent version of the 'WHO Laboratory Manual For The Examination And Processing Of Human Semen', the updated target population used to infer reference values included 3589 fertile subjects, representative of 12 countries and 5 continents, and 10 studies. We have critically evaluated the newly proposed distribution of semen examination results using an approach borrowed from clinical chemistry laboratories and based on the recommendations of the International Federation of Clinical Chemistry for estimation of reference intervals. Surprisingly, most prerequisites to produce common reference intervals through multicentric data were not met. Moreover, when we assessed with the bootstrap method the descriptive reference values obtained from raw data of the 10 individual studies for sperm concentration, sperm number, motility and normal forms, we found that none of the populations was completely correctly described by the reference centiles. We concluded that aggregated data used to build the reference distribution cannot be considered to originate from the same population, and this can result from real differences among individuals or different methodological approaches used in the various studies. Transferability conditions across studies did not seem to have been met. Our findings strengthen the relevance of concerns regarding the use of reference populations in the World Health Organization manual to discriminate between fertile and infertile men.