OBJECTIVE:To evaluate the clinical efficacy and safety of Heyan Kuntai capsule (HYKT) in treating women with infertility caused by diminished ovarian reserve (DOR).METHODS:One hundred eight eligible patients from three Chinese hospitals were randomly divided into an HYKT treatment group (n =55) or a dehydroepiandrosterone (DHEA) treatment group (n =53).Patients in the HYKT group were treated orally with four 0.5 g HYKT three times a day;patients in the DHEA group were treated with one 25.0 mg DHEA capsule three times a day.All patients were treated for 3 months and followed up over a 3-month period.RESULTS:Of 108 patients,12 dropped out:six from the HYKT group,and six from the DHEA group.Eleven patients got pregnant during the treatment.Serum anti-Müllerian hormone levels and antral follicle counts increased significantly in both groups after treatment (P ＜ 0.05) especially in the HYKT group (P ＜ 0.05).Serum follicle stimulating hormone (FSH) levels and FSH/luteinizing hormone ratios decreased (P ＜ 0.05) with no significant difference between the two groups.Estradiol levels in the HYKT group and DHEA-sulfate levels in the DHEA group both increased (P ＜ 0.05).The spontaneous pregnancy rates were 12％ and 11％ in the HYKT and DHEA groups,respectively (not significant).During the follow-up period,16 patients in the HYKT group underwent in vitro fertilization-embryo transfer (IVF-ET) and the number of retrieved oocytes was (5.1 ± 1.8).In DHEA group,20 patients underwent IVF-ET and the number of retrieved oocyte was (4.2 ± 1.9) (not significant);clinical pregnancy rates were 38％ in the HYKT group and 20％ in DHEA group (not significant).No significant adverse reactions were observed.CONCLUSION:HYKT can improve the ovarian reserve and hormone levels in patients with infertility caused by DOR.Pregnancy rates after HYKT treatment were similar to those of DHEA treatment.HYKT might be an altative to the treatment of infertility caused by DOR.