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

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.

Standards in reporting cryopreserved donor sperm characteristics: should they be reported post-thaw or post-wash?

An increase in the reliance on imported donor samples has been the consequence of a continued shortage of UK donors. Disputes can arise between suppliers and purchasers if the sperm quality is not as expected, yet there appears to be no requirement for the standardization of methods for sperm processing or analysis. Following analysis of 102 donor intrauterine insemination cycles, this study demonstrates that the motile sperm concentration is significantly (P < 0.05) reduced after the necessary removal of cryoprotectant before insemination. Suppliers of donor spermatozoa should therefore provide information on standards used for sperm assessment and whether analysis is performed before or after washing in order that purchasers are better informed about the quality of the end product they are committed to buying.

How strict should specimen acceptance or rejection criteria be for diagnostic semen analysis? An opinion.

Medical laboratory accreditation (previously by Clinical Pathology Accreditation UK Ltd and now by the United Kingdom Accreditation Service) has been integral to improving standards and service quality in the UK. With the recent introduction of the ISO15189 standard, all laboratories offering a clinical diagnostic service are required to demonstrate further improvement, with more emphasis on validation and assessment of the uncertainty levels associated with testing. This applies not only to 'bench testing', but also to the evidence-base for all pre-analytical and post-analytical procedures. To reduce the risk of external influences on andrology test results, semen sample rejection criteria were developed, including confirmation of patient identity, a strict time limit from sample production to testing, the use of toxicity-tested containers, a prescribed sexual abstinence and a need for complete sample collection. However, such criteria were originally developed by the World Health Organization in order to standardise analysis rather than reject testing outright, and should therefore be implemented with caution. Rejecting samples with normal semen parameters because they fail to meet some of the criteria as outlined above would be a waste of resources and adversely affect user (the person who requested or provided the sample) satisfaction. This document evaluates the evidence base underlying commonly used criteria for specimen rejection and suggests how they may be applied more pragmatically in order to improve efficiency and reduce the waste of resources.

Sperm donor recruitment within an NHS fertility service since the removal of anonymity.

The marked decline in the number of sperm donors recruited in the UK has been largely attributed to changes in regulations and in particular those related to the removal of anonymity. After a 5-year period of inactivity, the sperm donor bank in Nottingham was provided with limited resources to try and recruit donors who were willing to be identified on the HFEA register. Marketing was sporadic and at first low cost and the enquiry rate only increased significantly when the centre's website became operational and higher cost advertising was used. Over a 4-year period, a total of 151 enquiries gave rise to 14 useable donors at a cost of approximately £5,500 each. Donor sperm was generally of high quality having been density gradient prepared prior to cryopreservation and provided an overall ongoing pregnancy rate of 21.6% and 45.6% by IUI and IVF, respectively. The overall exercise demonstrated that identifiable donors were coming forward but in lower numbers compared to those observed before 2005. At current treatment prices, centres should be aware that recouping the costs of donor recruitment and processing may be difficult and that the cost of both donor sperm and donor insemination are likely to rise significantly.