Objective:To assess the efficacy of Zishen Yutai Pill compared with placebo on live birth rate among women following fresh embryo transfer cycles.Methods:We conducted a double-blind, multicenter, placebo-controlled, randomized trial to investigate whether administration of Zishen Yutai Pill would improve pregnancy outcomes among women undergoing fresh embryo transfer following in vitro fertilization or intracytoplasmic sperm injection. The primary outcome was live birth rate. Secondary outcomes were rates of implantation, biochemical pregnancy, clinical pregnancy, pregnancy loss, cycle cancellation, maternal, fetal and neonatal complications. A total of 2265 sample size (1∶1 in two groups) was used to detect a live birth rate difference between Zishen Yutai Pill and placebo. Participants were enrolled and randomized to receive 5 g of Zishen Yutai Pill or placebo orally, three times per day during the study using block randomization method. Results:Recruitment was completed between April 2014 and June 2017, with 2580 patients screened. Follow-up was completed in June 2018. Totally 2265 patients were randomized, 1131 to Zishen Yutai Pill group and 1134 to placebo group. Characteristics were similar between the two groups. In intention-to-treat analysis, the rates of live birth in Zishen Yutai Pill group and placebo group were 26.8% (303/1131) and 23.0% (261/1134), respectively, the difference was statistically significant ( RR=1.16, 95% CI=1.01-1.34, P=0.038). The implantation rates were 36.8% (482/1310) and 32.6% (410/1256) in Zishen Yutai Pill group and placebo group, respectively, the difference was statistically significant ( RR=1.13, 95% CI=1.01-1.25, P=0.027). The biochemical pregnancy rate in Zishen Yutai Pill group was 35.5% (402/1131) vs. 31.1% (353/1134) in placebo group, the difference was statistically significant ( RR=1.14, 95% CI=1.02-1.28, P=0.026). The rates of clinical pregnancy in Zishen Yutai Pill group and placebo group were 31.2% (353/1131) and 27.3% (310/1134), respectively, the difference was statistically significant ( RR=1.14, 95% CI=1.00-1.30, P=0.043). There were no significant differences between the two groups in the rates of pregnancy loss, maternal, or neonatal complications (all P>0.05). Conclusion:Zishen Yutai Pill increased the rate of live birth after fresh embryo transfer compared with placebo.

Objective:To assess the efficacy of Zishen Yutai Pill compared with placebo on live birth rate among women following fresh embryo transfer cycles.Methods:We conducted a double-blind, multicenter, placebo-controlled, randomized trial to investigate whether administration of Zishen Yutai Pill would improve pregnancy outcomes among women undergoing fresh embryo transfer following in vitro fertilization or intracytoplasmic sperm injection. The primary outcome was live birth rate. Secondary outcomes were rates of implantation, biochemical pregnancy, clinical pregnancy, pregnancy loss, cycle cancellation, maternal, fetal and neonatal complications. A total of 2265 sample size (1∶1 in two groups) was used to detect a live birth rate difference between Zishen Yutai Pill and placebo. Participants were enrolled and randomized to receive 5 g of Zishen Yutai Pill or placebo orally, three times per day during the study using block randomization method. Results:Recruitment was completed between April 2014 and June 2017, with 2580 patients screened. Follow-up was completed in June 2018. Totally 2265 patients were randomized, 1131 to Zishen Yutai Pill group and 1134 to placebo group. Characteristics were similar between the two groups. In intention-to-treat analysis, the rates of live birth in Zishen Yutai Pill group and placebo group were 26.8% (303/1131) and 23.0% (261/1134), respectively, the difference was statistically significant ( RR=1.16, 95% CI=1.01-1.34, P=0.038). The implantation rates were 36.8% (482/1310) and 32.6% (410/1256) in Zishen Yutai Pill group and placebo group, respectively, the difference was statistically significant ( RR=1.13, 95% CI=1.01-1.25, P=0.027). The biochemical pregnancy rate in Zishen Yutai Pill group was 35.5% (402/1131) vs. 31.1% (353/1134) in placebo group, the difference was statistically significant ( RR=1.14, 95% CI=1.02-1.28, P=0.026). The rates of clinical pregnancy in Zishen Yutai Pill group and placebo group were 31.2% (353/1131) and 27.3% (310/1134), respectively, the difference was statistically significant ( RR=1.14, 95% CI=1.00-1.30, P=0.043). There were no significant differences between the two groups in the rates of pregnancy loss, maternal, or neonatal complications (all P>0.05). Conclusion:Zishen Yutai Pill increased the rate of live birth after fresh embryo transfer compared with placebo.