The question whether there is an increased risk for major congenital malformations after IVF or ICSI was recently reviewed in two meta-analysis (83,84). The meta-analysis by Hansen et al. (83) indicated an overall increase after IVF and ICSI. This was also the case when only singletons, IVF children or ICSI children were analyzed separately. The pooled odds ratio risk for major birth defects was 1.32 (confidence interval 1.20-1.45). A metaanalysis by Lie et al. (85) compared major malformations in 5935 ICSI children to 13,086 conventional IVF children. The relative risk for a major malformation after ICSI was 1.2 (95% CI 0.97-1.28). The meta-analysis by Rimm et al. (84) confirmed the higher risk of major malformations in IVF
and ICSI children in comparison to spontaneously conceived children. There was no significant difference in the risk when IVF and ICSI were compared.
A multicentric cohort study (86) of the physical health of 5-yr-old children conceived after ICSI (n = 540), IVF (n = 538), or natural conception (n = 437) indicated that in comparison with natural conception the odds ratio for major malformations was 2.77 (CI 1.41-5.46) for ICSI and 1.80 (CI 0.85-3.81) for IVF children. Socio-demographic factors did not affect these results. The higher rate observed in the ICSI group was partially due to an excess in the (boys') urogenital system. In addition, IVF and ICSI children were more likely than naturally conceived children to have had a significant childhood illness, to have had a surgical operation, to require medical therapy, and to be admitted to hospital. It will be important to continue monitoring of these children. As reported by Ludwig (87), there are major gaps in valid data to assess major malformations after the different ART procedures as compared with spontaneously conceived children from fertile couples. This is the case for ovarian stimulation and intrauterine insemination. The major limitations of studies on major malformation rates include the absence of a control cohort, the use of historical controls with unclear definitions, the data collection in the control, and study group as well as in the definitions of the term "major malformation'' (88).
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