Objective: Primary outcome was to compare neurodevelopmental outcome at two years in intracytoplasmic sperm injection (ICSI) conceived children versus matched controls. Secondary outcome was to determine incidence of major congenital malformations and study perinatal outcome.
Design: Prospective cohort study.
Setting: Tertiary care perinatal centre over a period of 13 months.
Population: Seventy-six ICSI conceived children and 261 matched controls selected by matching for maternal age, sex, date of delivery, race, plurality and parity.
Methods: Mental Development Index (MDI) and Psychometric Development Index (PDI) of the Bayley's Scale of Development (BSID-II) and Vineland Adaptive Behaviour Scale (VABS) were used to assess the neurodevelopmental and functional outcome. The congenital malformations were classified according to ICD-9 code.
Main outcome measures: Primary outcome measure--neurodevelopmental and functional outcomes. Secondary outcome measure--congenital malformations and perinatal outcomes.
Results: Neurodevelopmental and functional outcome were comparable in both groups. The mean MDI score was 92 [16] versus 90 [14] in the study and control groups respectively. Fourteen (18.4%) in the ICSI group had MDI <85 compared with 87 (33%) controls (P= 0.002). On linear regression the MDI was independently affected by plurality (P= 0.001), maternal education and socio-economic status (P= 0.01). The study group had a lower gestation (36 [3] vs 37.1 [2] weeks; P= 0.005) and a higher incidence of prematurity <34 weeks [19 (25%)] vs [31 (12%)] P= 0.012]. Six (7.9%) of the ICSI babies and seven (2.7%) of the controls had a major congenital malformation (P= 0.05).
Conclusions: Children born by ICSI pregnancies did not have an adverse neurodevelopmental outcome. The incidence of major congenital malformations in ICSI needs further evaluation.