OBJECTIVE To observe the clinical efficacy of Ziyu Prescription in the treatment of polycystic ovary syndrome related infertility of kidney deficiency and its effect on endometrial receptivity.

METHODS A total of 120 patients with polycystic ovary syndrome related infertility of kidney deficiency were enrolled and randomly divided into a control group and a treatment group, with 60 cases in each group. After excluding dropout cases and excluded cases, 56 cases were completed in each group. The control group was treated with letrozole and placebo, while the treatment group was treated with letrozole and Ziyu Prescription. The treatment course of both groups was 3 menstrual cycles. The clinical pregnancy rate and ultrasound Salle score during the implantation window were the main outcome indicators. The traditional Chinese medicine (TCM) syndrome score and serum estradial (E₂), testosterone (T), anti-Müllerian hormone (AMH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), homeostatic model assessment of insulin resistance (HOMA-IR), serum E₂ and progesterone (P) levels during the implantation window were used as secondary outcome indicators. Multivariate Logistic regression and ROC curve analysis were used to evaluate the effect and predictive ability of ultrasound Salle score on pregnancy outcome. Multiple linear regression was used to evaluate the effect of estrogen and progesterone levels during the implantation window on ultrasound Salle score.

RESULTS After treatment, the clinical pregnancy rate and ultrasound Salle score during the implantation window in the treatment group were significantly higher than those in the control group (P < 0.05, P < 0.01). The total TCM syndrome score of the treatment group was significantly lower than that of the control group (P < 0.01); the serum T, LH/FSH, and HOMA-IR levels of the treatment group were significantly lower than those of the control group (P < 0.05, P < 0.01); the serum E₂ and P levels of the treatment group were significantly higher than those of the control group during the implantation window period(P < 0.01). Multivariate Logistic regression analysis and ROC curve analysis showed that ultrasound Salle score was significantly positively correlated with pregnancy rate and had a high predictive value for pregnancy outcome. Multiple linear regression analysis found that there was a linear relationship between the ultrasound Salle score and E₂ and P during the implantation window period, and the P level had a greater impact.

CONCLUSION Ziyu Prescription can improve the clinical pregnancy rate of patients with polycystic ovary syndrome related infertility of kidney deficiency, effectively improve their endometrial receptivity, regulate the levels of sex hormones and glucose metabolism, reduce the TCM syndrome score, and improve the reproductive quality of patients.