OBJECTIVE: To observe clinical efficacy and safety of exenatide combined with clomiphene citrate in the treatment of polycystic ovary syndrome with insulin resistance. METHODS: 98 patients with polycystic ovary syndrome complicated with insulin resistance were randomly divided into control group (49 cases) and observation group (49 cases). Control group was given Clomiphene citrate capsule 50 mg orally, once a day, for 5 d+Metformin enteric-coated tablet with initial dose of 0.25 g orally, twice a day, adjusted to 0.50-0.75 g orally, twice a day, for 3 menstrual cycles. Observation group was given Clomiphene citrate capsule (usage and dosage same as control group)+Exenatide injection 5 μg subcutaneously, twice a day, adjusted to 10 μg subcutaneously, twice a day, for 2 months. Clinical efficacies of 2 groups were observed as well as the levels of LH, FSH, LH/FSH and IR before and after treatment, ovulation and pregnancy of infertility patients after treatment. The occurrence of ADR was recorded. RESULTS: Total response rate,ovulation rate and pregnancy rate of observation group were significantly higher than that of control group, with statistical significance (P<0.05). Before treatment, there was no statistical significance in the levels of LH, FSH, LH/FSH and IR between 2 groups (P>0.05). After treatment, the levels of LH, LH/FSH and IR in 2 groups were significantly lower than before, and the observation group was significantly lower than the control group, the levels of FSH in 2 groups was significantly higher than before,and the observation group was significantly higher than the control group, with statistical significance (P<0.05). There was no statistical significance in incidence of ADR between 2 groups (P>0.05). CONCUSIONS:Exenatide combined with clomiphene citrate shows significant therapeutic efficacy for polycystic ovary syndrome complicated with insulin resistance and can increase ovulation rate and pregnancy rate through improving insulin resistance, but doesn’t increase the occurrence of ADR.