Preliminary report on the safety of a new herbal formula and its effect on sperm quality

Abstract

Purpose: Male infertility is a serious problem, and its prevalence has been increasing. Therefore, we investigated the safety of a new herbal formula and its effects on sperm quality.

Materials and methods: An in vitro cytotoxicity test in TM3 Leydig cells was performed to evaluate cell viability after administration of five types of herbs separately and of a new herbal formula containing these five. An in vivo test in male mice was performed to evaluate the influence of the new herbal formula on the reproductive organs and sperm quality. After the 8- and 28-day oral administration of the new herbal formula, the weights of the reproductive organs were measured and the sperm count and motility were evaluated.

Results: In the in vitro cytotoxicity test, less than 80% cell viability at concentrations of 500 mg/L and 1,000 mg/L of Rubus coreanus Miquel and Cuscuta chinensis Lam was observed. However, more than 80% cell viability was observed at all the tested concentrations of the new herbal formula. After the 8- and 28-day oral administration, there were no considerable changes in body weight. The weights of the testes, epididymis, and seminal vesicles after the 8- and 28-day oral administration were similar to those of the control. The sperm count and activity were significantly improved compared with those of the control group at 8 and 28 days after 100, 200, and 400 mg of oral administration.

Conclusions: The safety of the new formula and its positive effect on the sperm quality were observed after the oral administration of the formula.

Keywords: Infertility, male; Phytotherapy; Safety; Spermatozoa.

Fig. 1

Effect of KH-204 on the viability of TM3 Leydig cells. Each graph shows cell viability after the administration of Cornus officinalis Sieb. Et Zucc, Schizandra chinensis Baillon, Rubus coreanus Miquel, Cuscuta chinensis Lam, Lycium chinense Mill, and the new herbal formula at concentrations of 62.5 mg/L (A), 125 mg/L (B), 250 mg/L (C), 500 mg/L (D), and 1,000 mg/L (E) for 24 hours.

Fig. 2

Effect of the new herbal formula on sperm count and activity. (A) Sperm count and activity after 8-day oral administration of the new herbal formula. (B) Sperm count and activity after 28-day oral administration of the new herbal formula. ^ap<0.05 compared with that of the control group.

Fig. 3

Appearance of sperm after 28-day oral administration with KH-204. (A) Control, (B) KH-204 50 mg, (C) KH-204 100 mg, (D) KH-204 200 mg, (E) KH-204 400 mg (×200 magnification).