Objective To explore the clinical effect and safety of Kuntai Jiaonang（坤泰胶囊） in treating patients with hypofunction of ovarian reserve infertility. Methods Sixty-eight patients with hypofunction of ovarian reserve infertility were randomized into a treatment group（ 33 cases） and a control group（ 35 cases）. The treatment group was given oral Kuntai Jiaonang

2. 0 g each time

3 times each day. The control group was given oral dehydroepiandrosterone

25 mg each time

3 times each day. The course in both groups was 3 menstrual cycles. During treatment

patients’ medication

side effect and pregnancy were examined. At the end of treatment

follow-up was carried out for 4 cycles of in vitro fertilization and embryo transfer. Patients’ serum levels of basal follicle stimulate hormone（ FSH）

basal estradiol（ E2）

luteinizing hormone（ LH） and follicular stage anti-Mullerian hormone（ AMH）

as well as basal antral follicle number（ AFC）

clinical pregnancy rate of in vitro fertilization and embryo transfer during follow-up and periodic clinical pregnancy rate were compared between two groups before and after treatment.Results Compared between patients in two groups before and after treatment

there were no significant differences in levels of FSH

E2

LH and AFC（ P > 0. 05）. In the treatment group

5 patients did not go through in vitro fertilization and embryo transfer. The clinical pregnancy was 5 cases in the treatment group

and 9 cases in the control group.In the first cycle

the clinical pregnancy was 3 of 17 cases in the treatment group

and 1 of 21 cases in the control group. In the second cycle

the clinical pregnancy was 1 of 9 cases in the treatment group

and 2 of 20 cases in the control group. In the third cycle

one of two patients in the treatment group

and 4 of 6 patients in the control group were pregnant. In the forth cycle

there was no transfer patient in the treatment group

and the pregnancy in the control group was 2 of 2 cases. During the research

some patients in the control group had facial acne. No side effect was found in the treatment group. Conclusion The improvement of ovarian reserve function and clinical pregnancy rate in patients with hypofunction of ovarian reserve infertility by Kuntai Jiaonang was equivalent to that by dehydroepiandrosterone. Moreover

Kuntai Jiaonang seems to be safe.