Baozhu Granule as a Novel Treatment Strategy for Diminished Ovarian Reserve: A Prospective Clinical Trial.

Abstract

Diminished ovarian reserve (DOR), affecting more than 10% of reproductive-aged women, leads to impaired fertility and systemic health disturbances. Baozhu Granule, a novel Chinese herbal formulation, has shown potential ovarian-protective effects in preliminary studies. This exploratory clinical trial aimed to investigate the efficacy and safety of Baozhu Granule in patients diagnosed with DOR. In this prospective, single-arm, open-label trial, 134 women aged 18-45 years with confirmed DOR were enrolled. Participants received Baozhu Granule (20 g, twice daily) orally for 12 consecutive weeks. The primary outcome was the recovery rate of ovarian reserve, assessed by antral follicle count and serum biomarkers. Secondary outcomes included menstrual recovery and changes in the Kupperman menopausal index (KMI). Evaluations were performed at baseline and after 12 weeks of treatment. Of the 134 enrolled patients, 108 completed the full treatment course; 20 of these were unable to attend the final visit (Visit 3) due to COVID-19 restrictions. Among the 88 patients evaluable at Visit 3, 68.2% showed recovery of ovarian reserve. Menstrual recovery was reported in 45.9% of patients, and 42.9% showed alleviation of menopausal symptoms (reduction in KMI). Subgroup analyses indicated that younger age, detectable anti-Müllerian hormone levels, and lower baseline follicle-stimulating hormone levels were associated with higher rates of ovarian reserve and menstrual recovery. Specifically, the overall recovery rate was 85.2% at 12 weeks of observation. No serious adverse events were reported throughout the study period. In this exploratory study, Baozhu Granule was associated with improvements in ovarian reserve, restoration of menstrual cyclicity, and relief of menopausal symptoms in women with DOR, with a favorable safety profile. These preliminary findings suggest its potential as a therapeutic option for DOR; however, further randomized controlled trials are needed to confirm these results.