| ObjectiveTo discuss Qiangjing tablets on patients with male infertility of renal deficiency and blood stasis syndrome, which especially need for ICSI treatment of the patients with asthenoteratospermia, how to influence the sperm DNA fragmentation rate, nuclear proteins and ICSI pregnancy outcomes. And to further analysis the relationship between the sperm DNA fragmentation rate and fertilization rate of ICSI.Materials and MethodsWe have collected the couples, which need to intracytoplasmic sperm injection (ICSI) treatment for having a child form June 2014 to December 2015, in our reproductive medicine center, the second affiliated hospital Chengdu University of Traditional Chinese Medicine. According to the human semen examination and treatment of Laboratory Manual (WHO, 5th Edition,2009), the male patients who meet the PR (of movement) of sperm class<32%?and the normal morphology sperm<4%?are classed to asthenoteratospermia. And Accord to Guiding Principles of Clinical Research on New Drugs of Traditional Chinese Medicine, Andrology (2004 edition), and Chinese Andrology of Integrative Medicine (2010 edition), the male patients should meet the Chinese medical syndrome type of kidney deficiency and blood stasis. At the same time, the female should not accompanied with the uterus, adnexa uteri, endocrine and other aspects of reproductive dysfunction, from all above conditions, there are 72 couples had been researched in this article and randomly divided into experimental group and control group, and each group were 36 couples. The female were been under ICSI routine preoperative preparation, while the male patients in experimental group were treated by Qiangjing tablets (3 times a day, each time for 5 pills, one month for a course of treatment, and a total of 3 courses for the esperiment) which were made by the Teaching Hospital of Chengdu University of Traditional Chinese Medicine, and the male patients in control group were treated by Vitamin C (0.1g,1 time a day) and Vitamin E (0.1g,3 times a day) for 3 month. The T.C.M. syndrome score, sperm DNA fragmentation rate, sperm nuclear protein immaturation rate, fertilization rate and pregnancy rate of ICSI were analyzed before and after the treatment.Statistical calculations were performed using the SPSS21.0 and JMP9.0. Group quantitative data consistent with normal distribution using t test. The two two comparison between groups was compared with one factor analysis of variance, and the rank sum test is used for the variance is not homogeneous. Chi square test was used to compare the rates. Correlation analysis is used to describe the correlation between the two two variables. Acceptable significance level was set at p< 0.05.Results1. The experimental group treated by the Qiangjing tablets which were tonifying the kidney and promoting blood circulation, and through the analysis of the data after treatment, sperm DFI average was 12.62 ± 3.44%, Z=-8.25, P< 0.0001 (P< 0.05), with significant statistical difference.2. The control group treated by the Vitamin C and Vitamin E, and through the analysis of the data after treatment, sperm DFI average was 14.59 ±3.98%, Z=-4.30, P< 0.0001 (P< 0.05), with significant statistical difference.3. After treatment, the sperm DFI average of the experimental group was 12.62 ± 3.44%, the control group was 14.59 ± 3.98%, t= 2.07, P= 0.046< 0.05, and with statistical difference.4. The sperm nuclear protein immaturation rate in experimental group after treatment was 21.43 ±4.70%, Z=-2.74, P< 0.01, and with significant statistical difference.5. The sperm nuclear protein immaturation rate in control group after treatment was 22.32 ±7.61%, Z=-2.27, P=0.03,< 0.05, and with significant statistical difference.6. After treatment, the nuclear protein immaturation rate in experimental group was 21.43 ±4.70%, the control group was 22.32 ±7.61%, Z=-0.56, P= 0.058,>0.05, and did not with statistical difference.7. In the experimental group and the control group after ICSI operation, fertilization rate in the experimental group was 68.66%, In the control group, the fertilization rate was 41.31%, two groups compared with chi square test, P< 0.0001, less than 0.05, so the differences in fertilization rate of the two groups was statistically significant.8. In the experimental group and the control group after ICSI operation, the pregnancy rate in the experimental group was 68.66%, while in the control group was 41.31%, two groups compared with chi square test, P=0.487, more than 0.05, so the differences in fertilization rate of the two groups was not statistically significant.9. In the experimental group and control group, sperm DFI and ICSI fertilization rate were analyzed, the correlation analysis with statistical significance, with the increase of the sperm DFI, ICSI fertilization rate gradually decreased.10. After treatment, the two groups were analyzed on T.C.M. syndrome score, in the experimental group,13 cases were cured,17 cases were markedly effective,4 cases were effective,2 cases were ineffective, the control rate was 83.33%, the total effective rate was 94.44%; while in the control group,9 cases were cured,11 cases were markedly effective,6 cases were effective,10 cases were ineffective, the control rate was 55.55%, the total effective rate was 72.22%. The control rate and the total effective rate of the two groups were statistically significant differences, which showed that the Qiangjing tabtles could significantly improve the clinical symptoms of T.C.M..Conclusion1. Qiangjing tablets Can significantly improve the T.C.M. syndrome scores of patients with kidney deficiency and blood stasis syndrome.2. Compared with Vitamin C and Vitamin E, Qiangjing tablets can significantly improve the asthenoteratospermia patients'?sperm DNA fragmentation index and sperm nuclear protein immature rate.3. Compared with Vitamin C and Vitamin E, Qiangjing tablets can significantly improve the pregnancy rate of ICSI in asthenoteratospermia patients.4. There was no significant difference in the pregnancy rate after ICSI between the Qiangjing tablets and Vitamin C and Vitamin E.5. Sperm DNA fragmentation index of male infertility patients has correlation with fertilization rate after ICSI. With the increase of sperm DNA fragmentation, the fertilization rate of ICSI gradually decreased. |
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