Abstract: AIM: To observe the clinical effect of Guizhifulin capsule, together with Diane-35 and clomifene citrate on polycystic ovary syndrome (PCOS) with sterility. METHODS: From February 2009 to February 2011, 60 PCOS patients with sterility who visiting the out-patient clinic of Obstetrics and Gynecology Sterility Department, Second Affiliated Hospital, Chinese Medical University,were enrolled to be divided randomly into control group (Diane-35+clomifene citrate) and treatment group (Guizhifulin capsule + Diane-35+clomifene citrate).Before and after 3 months treatment, the changes of the following items were observed: body mass index(BMI),waist-to-hip ratio(WHR), hairness score, acne score, volume of ovary,total testosterone(TT),luteinizing hormone (LH), LH-to-Follicular Stimulating Hormone(FSH) ratio,fasting plasma glucose (FPG),fasting insulin(FINS). Additionally, the ovulation rate and pregnancy rate were detected after 3 treatments. RESULTS: (1)There was no statistical difference in WHR, hairness score,acne score between the treatment group and the control group. The volume of ovary was smaller both in the treatment group and control group. BMI was statistically decreased in the treatment group(P<0.05), and no in control group.(2)After treatment,there were statistically decrease in LH,LH-to-FSH ratio, TT ,and increase in SHBG both in treatment group and control group(P<0.05).There was statically decrease in FINS in treatment group(P<0.05), and no in control group(P>0.05).(3)The rate of ovulation and pregnancy was more in treatment group than that in control group, but there was no statisically difference (P>0.05). CONCLUSION: Guizhifulin capsule and Diane-35 and clomifene citrate are able to improve the status of genito-endocrine, glycolipin metabolism, sensitivity to CC and the rate of ovulation and pregnancy.

Key words: Polycystic ovary syndrome, Sterility, Guizhifulin capsule, Diane-35, Clomifene citrate