Received December 08, 2016
Accepted April 03, 2017

Since year 1992, the development ICSI has allowed infertile couples, in many of whom traditional IVF failed, to become parents, especially when there is a severe male infertility factor. This has generated considerable controversy over the safety of the procedure in the offspring. In this systematic review we seek to determine if there is evidence that the use of ICSI increases the risk of congenital malformations in children born from singleton pregnancies, in comparison with the births of children naturally conceived. We performed a literature search and found 104 publications, 21 of which were included in the analysis. The observational studies mostly show an increased risk for congenital malformation; the risk of congenital malformations is 7.1% in ICSI and 4.0% in the general population (OR 1.99 (95% CI [ 1.87 – 2.11 ]). However attributing the higher risk only to the ICSI procedure might be far-fetched, as the in vitro and simulation procedures, the patients’ pathology, the indication to the ICSI procedure, might also be associated to a a higher risk of malformation.