OBJECTIVE: To investigate the effects of Bushen huoxue cupailuan decoction on clinical effects and related indexes of infertility induced by polycystic ovary syndrome. METHODS: A total of 120 cases of polycystic ovary syndrome of kidney deficiency and blood stasis selected from our hospital were divided into observation group and control group according to random number table, with 60 cases in each group. From the 5th day of menstruation, control group was given Clomiphene citrate capsules 50 mg, qd; observation group was given 200 mL of Bushen huoxue cupailuan decoction, morning and night. Atreatment course lasted for 3 menstrnal cycle, both groups were treated for 1-2 courses. The number of follicles, endometrial thickness, ovarian volume and serum hormone levels (INS, LH, FSH, PRL, T, E2) were observed in 2 groups before and after treatment. The pregnancy rate were compared between 2 groups after treatment. RESULTS: Before treatment, there was no statistical significance in the number of follicles, endometrial thickness, ovarian volume or serum hormone levels between 2 groups (P>0.05). After treatment, the number of follicles, endometrial thickness and ovarian volume in 2 groups were all increased; the improvement of observation group was better than control group, with statistical significance (P<0.05). After treatment, the levels of FSH and E2 in 2 groups were increased significantly; the level of serum hormone in observation group was significantly better than control group, with statistical significance (P<0.05). The pregnancy rate of observation group was 63.33%, which was significantly higher than 46.67% of control group, with statistical significance (P<0.05). CONCLUSIONS: Bushen huoxue cupailuan decoction can effectively improve serum hormone lever, ovary condition and pregnancy rate in the infertility patients induced by polycystic ovary syndrome.