Pregnancy course and outcome after intracytoplasmic sperm injection: a controlled, prospective cohort study.
OBJECTIVE
To determine pregnancy course and major malformation rate after intracytoplasmic sperm injection (ICSI).


METHODS
Prospective, controlled, multicenter, nationwide German cohort study.


METHODS
Tertiary infertility centers in Germany.


METHODS
Three thousand three hundred seventy-two children and fetuses and 8,016 children and fetuses after the 16th week of gestation in pregnancies after ICSI and natural conception, respectively.


METHODS
Standardized prospective follow-up.


METHODS
Major malformation rate.


RESULTS
The major malformation rate was 8.7% (295/3,372) for the ICSI cohort and 6.1% (488/8,016) for the population-based control cohort (relative risk, 1.44 [1.25-1.65]). After adjustment for risk factors, the risk declined (adjusted odds ratio, 1.24 [95% CI, 1.02-1.50]). Regarding singletons, there was a significant difference for birth weight and gestational age, with a higher number of preterm and low birth weight children in pregnancies achieved after ICSI.


CONCLUSIONS
Children who are born after intracytoplasmic sperm injection have an increased risk of a major congenital malformation compared with those born after spontaneous conception. This risk is mainly due to paternal and maternal risk factors, which are more prevalent in couples who use ICSI for reproduction. An infertility-linked risk is highly probable for the observed findings. A technique-related risk, however, cannot be ruled out.
Katalinic
Alexander
A
Institute of Cancer Epidemiology & Institute for Social Medicine, University of Lübeck, Lübeck, Germany.
Rösch
Christine
C
Ludwig
Michael
M
D001724:Birth Weight; D015331:Cohort Studies; D016001:Confidence Intervals; D000013:Congenital Abnormalities / Q000453:epidemiology* / Q000209:etiology*; D005260:Female; D005865:Gestational Age; D006801:Humans; D015994:Incidence; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D016017:Odds Ratio; D011247:Pregnancy; D011256:Pregnancy Outcome; D012306:Risk; D020554:Sperm Injections, Intracytoplasmic / Q000009:adverse effects*