Objective: To observe the clinical effect and safety of Cordyceps sinensis (CS) combined with Jujing Pills (JJP) in the treatment of male infertility.

Methods: We randomly divided 90 male infertility patients into three groups of an equal number and treated them with JJP tid 5g once, CS bid 1g once and CS+JJP, respectively, all for 12 weeks. Before and after 4, 8 and 12 weeks of medication, we obtained the semen volume, sperm concentration, percentages of progressively motile sperm (PMS) and morphologically normal sperm (MNS) and sperm DNA fragmentation index (DFI), and compared them between the two groups of patients.

Results: The total therapeutic effectiveness rate was significantly higher in the CS+JJP than in the CS and JJP groups (96.42% vs 78.57% and 63.33%, P < 0.05), and so was PMS ([30.05 ± 10.24]% vs [24.74 ± 11.24]% and [22.71 ± 13.60]%, P < 0.01). The CS+JJP group also showed a higher percentage of MNS than the JJP group ([4.16 ± 2.86]% vs [2.73 ± 1.86]%, P < 0.01) but lower than the CS group ([5.03 ± 2.99]%) (P < 0.05). The sperm DFI was markedly lower in the CS+JJP than in the CS and JJP groups ([15.26 ± 6.93]% vs [15.90 ± 7.39]% and [16.85 ± 8.52]%, P < 0.05).

Conclusions: Cordyceps sinensis combined with Jujing Pills can effectively improve sperm quality and reduce sperm DFI. Based on the TCM theory of "mutual generation between metal and water", Cordyceps sinensis can significantly enhance the effectiveness of the kidney-tonifying therapy.

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