Objective:To evaluate the efficacy and safety of Chinese medicine Jianpi Antai formula in infertile women undergoing in vitro fertilization-embryo transfer(IVF-ET).Methods:A total of 300 infertile women who underwent 2 frozen embryo transfer procedures at the Reproductive Medicine Center,Sir Run Run Shaw Hospital were included in the study.The participants were randomly divided into study group and control group.The study group received routine medication plus the Jianpi Antai formula during the period of embryo transfer,while the control group received routine medication only.The general condition,embryo implantation rate,clinical pregnancy rate,live birth rate,and the blood routine and liver and kidney function were evaluated and compared between two groups.Results:There were 277 cases who completed the study,including 134 in the study group and 143 in the control group.The embryo implantation rate(68.7%vs.55.9%),the clinical pregnancy rate(56.7%vs.44.8%)and the live birth rate(50.7%vs.37.8%)in the study group were all higher than those in the control group(all P＜0.05).Subgroup analysis revealed that in patients of advanced age(≥35 years)and those with decreased ovarian reserve function(anti-Müllerian hormone＜1.68 ng/mL),the embryo implantation rate,clinical pregnancy rate,and live birth rate in the study group were all higher than those in the control group(all P＜0.05).During the follow-up period,there were no abnormalities in the basic vital signs of both groups,and no adverse events were reported.Conclusion:Jianpi Antai formula can safely improve the embryo implantation rate in infertile women undergoing IVF-ET,reduce the embryo miscarriage rate,increase the live birth rate as well as improve the clinical outcomes.