A comparison of pregnancy outcomes and congenital malformations in offspring between patients undergoing intracytoplasmic sperm injection and conventional in vitro fertilization: a retrospective cohort study.

OBJECTIVE:To explore whether intracytoplasmic sperm injection (ICSI) would increase the malformation risk in fetuses and live births compared with conventional in vitro fertilization (IVF). DESIGN:Retrospective cohort study. PATIENT(S):Data were collected from couples who underwent conventional IVF or ICSI from January 2009 to December 2019 at the Center for Reproductive Medicine of Peking University Third Hospital in the People's Republic of China. A total of 46,167 conventional IVF fresh transfer cycles and 33,247 ICSI fresh transfer cycles were included. INTERVENTION(S):Intracytoplasmic sperm injection and conventional IVF. MAIN OUTCOME MEASURE(S):The primary outcomes were congenital abnormalities in live births. The secondary outcomes included the pregnancy outcomes, the malformations among the miscarriages, specific types of malformations in live births, birth weight, and sex. RESULT(S):The rates of congenital malformations in conventional IVF and ICSI were 5.44‰ and 5.78‰, respectively. There was no statistically significant difference between the two groups, as indicated by the adjusted odds ratio of 1.098 (95% confidence interval 0.787, 1.532). The rates of specific malformations were comparable between ICSI and IVF. Additionally, no discernible disparities were noted in pregnancy outcomes, the malformations among the miscarriages,birth weight between the two groups. CONCLUSION:Our study suggested the safety of ICSI and provided novel evidence by comparing pregnancy outcomes and congenital malformations in offspring between patients undergoing conventional IVF and ICSI.