[Linggui Formula for asthenospermia with kidney deficiency and blood stasis: A randomized controlled trial]

To observe the effect and safety of the traditional Chinese medicine (TCM) Linggui Formula (LGF) in the treatment of asthenospermia with kidney deficiency and blood stasis.

This randomized controlled trial included 90 cases of asthenospermia with kidney deficiency and blood stasis treated in our hospital from September 2022 to September 2023, 45 by oral medication with LGF (the trial group) and the other 45 with oral levocarnitine solution (the control group), all for 12 weeks. We followed up the patients for 12 weeks, recorded the semen parameters, TCM syndrome scores, sexual hormone levels, pregnancy rates, and DNA fragmentation index (DFI) of the patients, and compared them between the two groups before and after treatment.

Totally, 82 of the patients completed the study, 42 in the trial and 40 in the control group. After treatment, the patients in the trial group showed significant increases in the percentage of progressively motile sperm (PMS) (from ［19.25±3.08］% to ［38.57±4.99］%, P< 0.05), total sperm motility (from ［32.29±3.64］% to ［46.50±4.77］%, P< 0.05) and sperm concentration (from ［83.9±37.2］ to ［95.1±34.9］× 10⁶/ml ］, P< 0.05), and so did the controls in PMS (from ［19.75±4.28］% to ［34.46±5.07］%, P< 0.05), total sperm motility (from ［33.02±4.93］% to ［43.11±4.72］%, P< 0.05) and sperm concentration (from ［85.2±39.7］ to ［88.1±35.2］ × 10⁶/ml , P< 0.05), all even more significant in the trial than in the control group (P< 0.05). No statistically significant difference was observed in the semen volume either in the trial (from ［3.38±0.38］ to ［3.24±0.45］ ml, P> 0.05) or in the control group (from ［3.46±0.52］ to ［3.30±0.37］ ml, P> 0.05), or between the trial and control groups (P> 0.05), or in the sexual hormone levels, pregnancy rates, and sperm DFI between the two groups before and after treatment (P> 0.05). Both groups of patients had good safety profiles without serious adverse reactions.

Linggui Formula can improve the percentage of PMS in asthenospermia patients with kidney deficiency and blood stasis, potentially enhancing pregnancy rates and with a good safety.