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An international collaborative study of icsi:child and family outcomes (ICSI-CFO)

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Project's original aim was to investigate the implications for family health and the health of children conceived after Intracytoplasmic Sperm Injection (ICSI), a new technology in the treatment of infertility which is now used in over 750 assisted reproductive clinics in Europe. Project's actual outcome: We assessed 1523 children across 5 European nations (UK, Belgium, Sweden, Denmark and Greece) This study was the most comprehensive to assess the health of children born after assisted conception in the world and is consistent with the fact that over 100,000 ICSI children had been born in the EU by 1998. The number of children assessed was slightly less than originally planned (1650) but as the project was very well powered to assess core outcomes AND the index case children (i.e. ICSI) were all recruited then this had no overall bearing on outcomes. All other targets were achieved in this project, however not exactly in the time frame allowed. This overrun did not add costs to the EU budget. The budget offered was 50% of that asked for and subsequently we had inadequate statistical support. This has resulted in delay in the publication of data from the project. However; it is now almost fully published after being presented at the European Society for Human Reproduction and Embryology in Madrid 2003 meeting. The work was also released to the general press. Broad dissemination and use intentions for the expected outputs: The information derived from this ICSI-CFO study will be available to all families considering assisted conception from fertility clinics. It concludes that allowing for small increases in congenital anomalies that these children are healthy; avoiding fears that they may be an effect from the ICSI technique itself. The study was also the first to look at the health of IVF children 'per se' it thus also confirms for families, fertility treatment clinics, public health planning organisations and other organisations (such as NGO'S) that these two groups of children appear to be healthy. It underpins the fact that the best outcome from an IVF pregnancy is a single baby and the conclusions of this study should be in no way extended to twins or triplets. Further study of these children is intended as they grow into adults.

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