| Objective: This study aims to assess the clinical efficacy of Kuntai Capsules in the treatment of infertile patients with diminished ovarian reserve of kidney yin deficiency type (KYD-DOR). Methods: A total of 78 patients diagnosed with KYD-DOR infertility between June 2024 and October 2025 were recruited and randomly allocated to either a control group (receiving placebo in combination with the phased therapy with estrogen-progesterone plus ovulation-inducing drugs) or an observation group (receiving Kuntai Capsules in combination with the phased therapy). Evaluations included calculation of menstrual cycles and syndrome scores, measurement of serum hormones (FSH, LH, E2 and AMH), ultrasound parameters (AFC, endometrial thickness and RI) and immune-active cytokines (IL-2, IFN-γ and TNF-α). Clinical pregnancy outcomes, including pregnancy and early miscarriage rates, were monitored post-treatment. Clinical efficacy was evaluated by calculating the overall response rate in both groups. The safety of the treatment regimen were preliminarily evaluated in both groups. Results: The observation group demonstrated a significantly higher overall response rate (89.74%) compared to the control group (71.79%) (P < 0.05). Notable improvements in kidney yin deficiency syndrome and menstrual symptoms such as irregular menstruation and abnormal menstrual bleeding were observed in the observation group, with significant reductions in menstrual and syndrome scores relative to baseline and the control group (P < 0.05). After the treatment, the observation group exhibited significant decreases in serum FSH, LH and FSH/LH levels (P < 0.05), alongside significant increases in E2 levels and endometrial thickness (P < 0.05). AMH levels and AFC were significantly elevated, while RI values were significantly reduced compared to both pre-treatment values and the control group (P < 0.05). Additionally, serum concentrations of IL-2, IFN-γ, and TNF-α were markedly decreased in the observation group relative to baseline and controls (P < 0.05). The clinical pregnancy rate in the observation group (48.72%) was significantly greater than that in the control group (20.51%) (P < 0.05). The safety profile of the treatment regimen was deemed satisfactory in both groups. Conclusion: Kuntai Capsules effectively enhance ovarian reserve function and endometrial receptivity in patients with KYD-DOR infertility, thereby improving pregnancy rates and overall clinical outcomes. These therapeutic effects may be mediated through the downregulation of immune-active cytokines. |