CASA has been used in reproductive medicine and pathology laboratories for over 25 years, yet the 'fertility industry' generally remains sceptical and has avoided automation, despite clear weaknesses in manual semen analysis. Early implementers had difficulty in validating CASA-Mot instruments against recommended manual methods (haemocytometer) due to the interference of seminal debris and non-sperm cells, which also affects the accuracy of grading motility. Both the inability to provide accurate sperm counts and a lack of consensus as to the value of sperm kinematic parameters appear to have continued to have a negative effect on CASA-Mot's reputation. One positive interpretation from earlier work is that at least one or more measures of sperm velocity adds clinical value to the semen analysis, and these are clearly more objective than any manual motility analysis. Moreover, recent CASA-Mot systems offer simple solutions to earlier problems in eliminating artefacts and have been successfully validated for sperm concentration; as a result, they should be viewed with more confidence in relation to motility grading. Sperm morphology and DNA testing both require an evidence-based consensus and a well-validated (reliable, reproducible) assay to be developed before automation of either can be of real clinical benefit.

CASA in the medical laboratory: CASA in diagnostic andrology and assisted conception

Post-vasectomy semen analysis (PVSA) is the procedure used to establish whether sperm are present in the semen following a vasectomy. PVSA is presently carried out by a wide variety of individuals, ranging from doctors and nurses in general practitioner (GP) surgeries to specialist scientists in andrology laboratories, with highly variable results.Key recommendations are that: (1) PVSA should take place a minimum of 12 weeks after surgery and after a minimum of 20 ejaculations. (2) Laboratories should routinely examine samples within 4 h of production if assessing for the presence of sperm. If non-motile sperm are observed, further samples must be examined within 1 h of production. (3) Assessment of a single sample is acceptable to confirm vasectomy success if all recommendations and laboratory methodology are met and no sperm are observed. Clearance can then be given. (4) The level for special clearance should be <100 000/mL non-motile sperm. Special clearance cannot be provided if any motile sperm are observed and should only be given after assessment of two samples in full accordance with the methods contained within these guidelines. Surgeons are responsible both preoperatively and postoperatively for the counselling of patients and their partners regarding complications and the possibility of late recanalisation after clearance. These 2016 guidelines replace the 2002 British Andrology Society (BAS) laboratory guidelines and should be regarded as definitive for the UK in the provision of a quality PVSA service, accredited to ISO 15189:2012, as overseen by the United Kingdom Accreditation Service (UKAS).

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2016 Laboratory guidelines for postvasectomy semen analysis: Association of Biomedical Andrologists, the British Andrology Society and the British Association of Urological Surgeons

The change to HPV testing as the primary screening modality is under way or imminent in the Cervical Screening Programmes (CSP) of the UK nations. This will necessitate major structural changes in all cytopathology laboratories, both in those that continue to provide a service to the CSP and those that do not. This article describes the development (from an existing service) and subsequent United Kingdom Accreditation Service (UKAS) accreditation of andrology testing in a District General Hospital setting, describing key areas for development and utilising cytopathology and histopathology staff of various grades and thus providing one avenue of skill redeployment for those cytopathology staff who will no longer provide morphological screening expertise to the CSP. This article is protected by copyright. All rights reserved.

Andrology and accreditation - An opportunity for Cytologists.

The increasingly stringent laboratory-approach to diagnosing azoospermia for post-vasectomy semen analysis (PVSA) continues to be at odds with the simpler approach desired by clinicians. This study describes the analysis of 10 years of PVSA and discusses the outcome in relation to risk, cost and assesses whether more stringent procedures are required. PVSA was performed on 4788 patients initially using a 2-test strategy (16 and 20 weeks post-surgery), moving to 1 test during 2013-2014. Azoospermia was confirmed by the analysis of 10 µl of semen followed by 10 µl of centrifuged pellet. In total, there were 9260 tests with a median of 1.93 tests/patient and 18.7 weeks to clearance. Surgical failure occurred in 1.75%, falling to 1.1% between 2011 and 2016. There were no cases of unwanted pregnancy, recanalization or complaints although misdiagnosis was detected in 1 case as a result of failure to confirm patient identification. Azoospermia performed according to World Health Organization (WHO) guidelines is sufficiently robust to confirm success/failure of vasectomy. With uncertainty surrounding the diagnosis, efforts to improve detection of occasional non-motile sperm are futile, cost more and fail to reduce risk of inappropriate clearance. Misdiagnosis is more likely from patient identification error and mitigation may include reverting to the safety net of a 2-test strategy.

Is azoospermia the appropriate standard for post-vasectomy semen analysis? Or an unachievable goal of best practice laboratory guidelines.

Couples trying to conceive or providing samples for Assisted Reproductive Technologies (ART) are advised against the use of lubricant-gels due to the risk of sperm-toxicity. However, gels now exist which are specifically formulated to help couples conceive but without consensus on their toxicity relative to non-specialist products. This study tested gels recently introduced as 'sperm friendly' (FertilSafe Plus, Fertile Check) alongside established lubricants intended for pleasure only using a recently published toxicity testing regime. Computer Assisted Sperm Analysis (CASA) was performed at 1 and 2 h on donor sperm (n = 12) pre-incubated with each gel (10% v/v) and controls. All gels led to a significant loss of motility/velocity at 1 and 2 h (p < 0.01), with the most significant loss from the 2 Durex pleasure products (11% and 15%, vs 47% progression) at 60 min, although these performed better than saliva (used as negative control). Incubation with FertilSafePlus led to the smallest loss of motility (24% vs 47%) at 1 h. Saliva and products designed for lubrication only exhibited the most negative effect on motility and those marketed as 'sperm safe' could be considered the best performers. Whether these affects are due to direct toxicity or are indirect due to other factors such as viscosity, pH or osmolality remains uncertain.

Sperm toxicity testing on lubricant gels: should we be recommending 'fertility-friendly' specialist products?

In order to ensure the quality and integrity of diagnostic semen analysis results, materials used should be tested to ensure that they do not interfere with sperm function. As a toxicity test, complex sperm function testing may be considered controversial, since the fertilizing capacity of single sperm can never be assured. In preference, sperm motility offers a unique means of assessing the toxicity of reagents and materials before they are used in routine practice. Motility is the semen parameter most likely to be influenced by the external environment. Indeed, it is the main reason that laboratories insist on supplying their own approved specimen containers and ensuring that patients, as far as possible, adhere to strict conditions for sample collection and transport prior to testing. This differs to other indirect tests of toxicity such as the mouse embryo assay, whereby the rate of mouse pre-implantation embryo development to the blastocyst stage is compared. This guideline is aimed at health care scientists who deal with andrology in both general pathology and specialised fertility laboratories, and provides a model approach to sperm toxicity testing. For assisted reproduction clinics, the same methodology can be used to test any consumables that are used for sperm processing, and as an indirect guide for any consumables that come into direct contact with oocytes and pre-implantation embryos.

Sperm toxicity testing: UK best practice guideline from the Association of Biomedical Andrologists

Vasectomy is the surgical procedure used for male contraception. Traditionally, operative success has been established by the issue of a laboratory report stating the achievement of azoospermia. The purpose of this study is to establish if this is an achievable or realistic status and if a change to the current best practice would provide an acceptable and cost-effective alternative. In principle, human fecundity is complex and measured in probabilities, which is inconsistent with the implied absolute requirement to establish the complete absence of spermatozoa.

M. T. Tomlinson

Papers

Sperm toxicity testing: UK best practice guideline from the Association of Biomedical Andrologists

Use of large-volume, fixed-depth, disposable slides for post-vasectomy semen analysis.