Abstract：Objective：To observe the clinical effect of Bushen Shugan Tiaozhou method combined with Letrozole (LE) for infertility due to polycystic ovary syndrome (PCOS). Methods：A total of 100 cases of PCOS patients with infertility were divided into the treatment group and the control group according to the random number table method，with 50 cases in each group. The control group was treated with LE，and the treatment group was additionally treated with Bushen Shugan Tiaozhou Method based on the treatment of the control group. Before and after treatment， the levels of follicle stimulating hormone (FSH)， testosterone (T)， luteinizing hormone (LH)， and anti- müllerian hormone (AMH)， and the traditional Chinese medicine (TCM) syndrome scores were compared between the two groups. The follicle diameter， number of follicles (follicle diameter>16mm)，and endometrial thickness were compared between the two groups on the day of human chorionic gonadotropin (HCG) injection. The clinical effects， incidence of adverse reactions and pregnancy status were evaluated in the two groups. Results：During treatment， 2 cases were lost and 48 cases were completed in the control group；2 cases were lost and 48 cases were completed in the treatment group. The total effective rates，ovulation rates，pregnancy rates，and live birth rates in the treatment group were higher than those in the control group (P＜0.05). After treatment，the TCM syndrome scores，and the levels of LH and LH/FSH in serum in the two groups，as well as the levels of AMH and T in the treatment group were decreased when compared with those before treatment (P＜0.05)； the TCM syndrome score， and the levels of LH， LH/FSH and T in serum in the treatment group were lower than those in the control group (P＜0.05). There was no significant difference being found in the comparison of FSH levels in serum between the two groups and the levels of AMH and T in the control group before and after treatment (P＞0.05). The endometrial thickness on the day of HCG injection in the treatment group was higher than that in the control group (P＜0.05). There was no significant difference being found in the comparison of number of follicles (follicle diameter＞16 mm)， follicle diameter，and incidence of adverse reactions between the two groups on the day of HCG injection (P＞ 0.05). Conclusion：Bushen Shugan Tiaozhou Method combined with LE has a definite curative effect in treating infertility due to PCOS，and can regulate the hormone levels，improve the endometrial thickness， and increase ovulation and pregnancy rates，with relatively high safety.