Randomized Controlled Study On Yishen Huoxue Decoction Treatment For SDF And Embryo Quality In Varicocele Patients With Kidney Deficiency And Blood Stasis Syndrome

ObjectiveTo investigate whether the sperm DNA fragments and embryo quality in varicocele patients with kidney deficiency and blood stasis could be improved by Yishen Huoxue Decoction,and explore the safety of Yishen Huoxue decoction in the treatment of such patients.MethodsRoutine semen,sperm DNA fragments and etiological examination were performed on male infertility patients willing to undergo IVF-ET treatment.According to TCM syndromes and the above inspection,kidney deficiency and blood stasis patients with varicocele and abnormal sperm DNA fragments were screened out.120 patients were planned to be included and divide into three groups(Yishen Huoxue decoction group 39 cases,vitamin E group 37 cases and blank control group 44 cases)according to the random number table method.All treatments last for an uninterrupted period of 12 weeks prior to IVF treatments under the cooperation with good living habits.The sperm routine parameters and SDF of the above groups were tested respectively before and after the intervention.Compare the differences of the above indicators before treatment in order to evaluate the comparability of the three groups,and compare the difference of each group before and after intervention.The above indexes,subsequent IVF-ET embryos quality(fertilization rate,cleavage rate,embryo rate available,high quality embryo rate)and security were compared among three groups after interventions.Results(1)108 kidney deficiency and blood stasis patients with varicocele and abnormal sperm DNA fragments were included into the study.There were 36 cases in the Yishen Huoxue Decoction group,35 cases in the vitamin E group,and37 cases in the blank control group.During the intervention,1 case in the Yishen Huoxue decoction group and 2 cases in the blank control group fell off.(2)Comparing the sperm parameters and SDF before intervention,three groups have the comparability.(3)Compared with pre-treatment,post-treatment SDF was significantly improved in each group.The z values were-13.105,-6.829 and-6.697respectively(all P < 0.01).There were different degrees of improvement in individual and total parameters of semen.(4)After treatment,significant differences in SDF was observed,=3.37,P =0.038.Multiple comparisons revealed statistical differences between the Yishen Huoxue decoction group and the blank control group(P=0.048).There were no statistically significant differences in the other parameters.(5)The SDF improvement rates of the above three groups were 62.857%,42.857% and 37.143%(=5.116,P = 0.077),and cure rates were 45.714%,31.429% and 31.429% respectively(=2.062,P = 0.357),with no significant difference between the groups.(6)After treatment,embryo parameters(fertilization rate,normal fertilization rate,cleavage rate,available embryo rate and high-quality embryo rate)were compared between the normal and abnormal SDF groups.There were statistically significant differences in available embryo rate(z =4.889,P < 0.001),high quality embryo rate(z =6.148,P < 0.001)and normal fertilization rate(z =3.373,P =0.001),while the other indicators had no statistically significant differences.(7)There was no significant difference in fertilization rate,normal fertilization rate,cleavage rate and available embryo rate among the three groups,while the Yishen Huoxue decoction group was significantly higher than the other two groups in high quality embryo rate(=17.233,P < 0.001).(8)The syndrome type improvement rate of kidney deficiency and blood stasis had a significant difference,respectively 82.857%(29/35),57.143%(20/35),and 51.429%(18/35).Chinese medicine intervention group was significantly better than the other two groups and no significant adverse events were observed.(9)No serious adverse reactions/events were observed in each group.The stools of 1 patient in the Yishen Huoxue decoction group were slightly soft.No abnormalities were observed in blood routine examination,liver and kidney function.ConclusionSDF would affect the developmental potential of embryos.In varicocele patients with kidney deficiency and blood stasis,SDF could be improved by the above empirical treatments in clinic,including lifestyle adjustment,vitamin E and traditional Chinese medicine.Compared with the other two groups,Yishen Huoxue decoction can effectively reduce SDF and improve the high-quality embryo rate obtained by IVF,which maybe more suitable for such infertility patients in clinical treatment.