OBJECTIVEThe multi-center, randomized, double-blind, double-simulated and positive-control trial was used to verify the contribution degree of Bushen Huoxue for the treatment of ovulatory dysfunction caused infertility, which provided scientific basis for clinical treatment.

METHODAccording to diagnostic, inclusion and exclusion criteria, we observed 349 patients which were divided into the treated group (n = 177, treated with Bushen Huoxue ricipe) and control group (n = 172, treated with clomiphene). Ovulation rate, pregnancy rate, clinical effective rate of traditional Chinese medicine, endometrium and diameter of dominant follicle were observed. Serum reproductive endocrine hormones were assayed before and after treatment.

RESULTThe treated group showed ovulation rate of 69.34%, with pregnancy rate of 41.35%. The clinical effective rate of treated group and control group were 91.73% and 80.77%. There was remarkable difference in endometrium (P < 0.05) and remarkbale difference in sex hormones PRL and E₂in treated group at prior-treatment and post-treatment (P < 0.05). No adverse effects were found in the experiment. Security indicators did not show abnormal change.

CONCLUSIONThe comparison between the two groups showed that the treated group was significantly different from control group in the pregnancy rate (P < 0.05), without notable difference in ovulation rate. There was significant difference in clinical effective rate between the treated group and control group. Both the two groups could contribute to the mature development and discharge of the follicles. The growth of endometrium and endometrial receptivity in the treated group were higher than control group. The treated group has regulatory effect on PRL and E₂.