Subgroup analysis based on rates of clinical pregnancy
REGRESSION
Totally 2265 infertile women undergoing fresh embryo transfer cycles entered into the ITT analysis. In the entire population, ZYP showed a significantly higher clinical pregnancy rates than placebo (31.2% vs 27.3%, respectively; OR 1.21; 95% CI 1.01-1.45) (Forest plot of clinical pregnancy rates among subgroups. Odd ratio (OR) was calculated using logistic regression model, with 95% confidence intervals (CI) presented. Age and site were selected for adjustment of OR. Since not all participants underwent embryo transfer, regression and comparison among the last two subgroups (i.e., good quality embryo transfer, embryo transfer number) were calculated among population undergoing embryo transfer. A total pf 1313 participants underwent embryo transfer, 670 in ZYP group and 643 in placebo.Pregnancy outcomes in AMA subgroup.Baseline characteristic analyses showed that two treatment arms were well-balanced in AMA subgroup (Characteristics of patients older than 35 years for the intention-to-treat analyses.Data are mean ± SD, n (%) or median (interquartile range).ZYP, Zishen Yutai Pill; yr, year; IVF, in vitro fertilization; BMI, body mass index; AFC, antral follicular count; ECycle responses and pregnancy outcomes of patients older than 35 years in study population for intention-to-treat analyses.Data are n (%) or median (IQR range).ITT, intention-to-treat set; ZYP, Zishen Yutai Pill; CI, confidence interval; IQR, interquartile. P-values <0.05 were considered statistically significant.Implantation rate = Number of gestational sacs/number of embryos transferred.
Part of the pregnancy outcome data has been published in the 