Since its introduction in 1992, intracytoplasmic sperm injection (ICSI) has
became a popular assisted fertilization technique proven very efficient in
treating male factor infertility, Many healthy children have been born wor
ldwide from this procedure, and their physical and mental development appea
rs to be within the normal limits. However, because of the peculiarity of t
he technique and the poor characteristics of the spermatozoa used, concern
about the safety of ICSI still exist. In this article, we analyze the in vi
vo development of embryos conceived after ICSI as well as the obstetric out
come, occurrence of chromosomal abnormalities, and rate of congenital malfo
rmations in neonates born as a result of this treatment. A total of 2435 co
uples were studied in whom the male partners were presumed to be the cause
of repeated failed attempts at in vitro fertilization (IVF) or had semen pa
rameters that were unacceptable for conventional IVF treatment. Pregnancies
resulting from 3573 ICSI cycles were analyzed; pregnancy outcome data were
obtained from the records of obstetrician-gynecologists and/or pediatricia
ns. The overall clinical pregnancy (fetal heartbeat) rate was 44.8% with a
resultant delivery rate of 39.2% per ICSI cycle (n = 1388). In 37 of the 77
miscarriages fop which cytogenetic data were available, an autosomal triso
my was found in each and 29 additional pregnancies were terminated because
of a chromosomal abnormality revealed by prenatal diagnosis. There was an e
qual distribution of vaginal deliveries and cesarean sections (n = 682 and
n = 658, respectively). Of the 2059 neonates resulting from ICSI treatment,
38 (1.8%) presented with congenital abnormalities (22 major and 16 minor).
When the frequency of miscarriages and congenital malformations was analyz
ed in terms of semen origin, the outcome was no different between ICSI and
IVE The course of pregnancies and occurrence of congenital malformations fo
llowing treatment by ICSI are within the ranges obtained following conventi
onal IVF.