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While intracytoplasmic sperm injection (ICSI) is the most significant advance in assisted reproductive technology (ART) for the alleviation of male factor subfertility, its use has become increasingly widespread and indiscriminate in ART clinics, extending well beyond the reasons for its necessary application. But ICSI is not “better” than IVF using any established outcome metric. Indeed, available evidence indicates that ICSI yields fewer embryos per treatment cycle, embryos which may have impaired developmental potential compared to IVF-derived embryos. This chapter investigates the basis for the over-use of ICSI, and identifies risks to which couples are exposed by the unjustified use of ICSI: a debate that has been raging for two decades, and is now also extending into considerations of “andrological ignorance”, how ICSI has effectively blocked scientific advances in andrology, and how obligate ICSI has effectively transferred the treatment burden for male factor infertility to the female partner, who is expected to undergo possibly unnecessary controlled ovarian hyperstimulation, oocyte retrieval and embryo transfer procedures.
Public concern over high-profile mistakes in IVF clinics and the concomitant increase in governmental regulation, have given rise to widespread recognition of the need for accreditation of IVF clinics. Modern accreditation schemes are largely based on the principles of ISO 9001 and related standards, at the heart of which lies the expectation of a formal quality management system. Risk analysis and risk minimization are also being demanded of IVF clinics, but many only have limited understanding of how to approach these essential management tasks. This book brings together the basics of quality management and risk management, focussing on 'prophylactic management' - prevention rather than cure. Each chapter in this new edition is fully updated and extended to include new material such as, quality and risk management in the ART clinic, and an illustrative example of a 'well-run' clinic. This is the essential guide for clinicians and IVF laboratory staff.