• We have obtained a database of a ten year experience of 12,000 ART cycles performed in a high performing IVF laboratory. This study will explore process variation over time and its relationship to pregnancy outcome. We will determine whether SPC may be employed to monitor staff education and development of clinical competence for skills such as ICSI and embryo biopsy in the laboratory and embryo transfer in the clinical practice.
• We are applying to the American SART registry to study three years of data from groups of high performing and low performing Centers. The purpose of this study is to gather normative data regarding the degree of process variation as a function of clinic performance and to ascertain whether variation in specific steps in the IVF process is related to outcome.
• Prospective study of statistical process control in clinical IVF laboratory practice: This is an international study designed to examine the utility of SPC as a quality control tool. Participating ART units will be provided with a cloud-based embryology electronic medical record to record embryology data and pregnancy outcomes. Data from this investigation will be used to design a software tool to provide ART units with realtime quality control feedback.
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