Abstract：Objectives：To observe the clinical effect of Jianpi Yiqi Huashi prescription combined with clomiphene citrate for infertility caused by polycystic ovary syndrome(PCOS) of spleen- kidney yang deficiency type. Methods ： A total of 146 cases of patients with infertility caused by PCOS of spleen-kidney yang deficiency type were divided into the observation group and the control group according to the random number table method，with 73 cases in each group. Both groups were treated with clomiphene citrate tablets， and the observation group was additionally treated with Jianpi Yiqi Huashi prescription. Both groups were treated for three courses， each menstrual cycle being a course. The clinical effect and the rates of ovulation and pregnancy in the two groups were compared. Before and after treatment， the Chinese medicine syndrome scores and the levels of sex hormone in serum in the two groups were compared. Results：The total effective rate was 93.15% in the observation group， higher than that of 82.19% in the control group(P＜0.05). After treatment， the Chinese medicine syndrome scores in the two groups were decreased when compared with those before treatment(P＜ 0.05)，and the Chinese medicine syndrome score in the observation group was lower than that in the control group(P＜0.05). The ovulation rate was 62.94% in the observation group and 47.25% in the control group；the pregnancy rate was 20.55% in the observation group，and 8.22% in the control group；the rates of ovulation and pregnancy in the observation group were higher than those in the control group(P＜0.05). After treatment，the levels of testosterone(T)，luteinizing hormone(LH) and estradiol(E2) in serum in the two groups were decreased when compared with those before treatment(P＜0.05). The levels of T，LH and E2 in serum in the observation group were lower than those in the control group(P＜0.05). Conclusion：Jianpi Yiqi Huashi prescription combined with clomiphene citrate for infertility caused by PCOS of spleen- kidney yang deficiency type can effectively alleviate the clinical symptoms of patients， regulate the levels of sex hormone in serum， and promote ovulation and pregnancy，whose curative effect is better than that of simple clomiphene citrate.