| ObjectiveTo observe the safety and efficacy of Chaihuangzanyu prescription in the treatment of male infertility(kidney deficiency and liver depression)after IVF-ET/ICSI failure.Methods1 Study designRandomized,positive drug control.2 ObjectiveA total of 78 patients with male infertility(kidney deficiency and liver depression type)after IVF-ET/ICSI failure were included from December 2018 to October 2019 at andrology department in Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine.According to the method of random number table,the participants were divided into experimental group(n=39)and control group(n=39).3 Therapeutic methodThe experimental group was given Chaihuangzanyu prescription composed of cooked land(15g),Bupleurum(12g),yam(10g),Hypericum perforatum(6g),fried Atractylodes macrocephala(15g),Chinese wolfberry(l0g),fried malt(10g),Centella asiatica(20g),twice daily,200ml per time.And the patients in control group took levocarnitine oral liquid(manufacturer:northeast Pharmaceutical General Factory).Approval number:national medicine:H19990372,twice daily,1g per time.Patients in both groups were treated with drugs for 12 weeks and followed up for 24 weeks.4 Observation indexPatients' general demographic data were obtained as well as therapeutic index:curative effect index:?sperm parameters(including sperm density,semen volume,PR grade sperm,PR+NP grade sperm);?TCM symptom score;Follow-up index:clinical pregnancy rate;Safety index:blood routine,urine routine,liver function(ALT,AST),renal function(BUN,CR),electrocardiogram and adverse reactions during medication.Results1 Drop-off and withdeawA total of 78 patients were enrolled in this study,8 cases fell off during the study period,and the total drop-out rate was 10.26%.There were 4 cases in the experimental group and 4 cases in the control group.The 8 cases were documented with the first visit,data after treatment were unavailable,they were removed from the analysis,the rest 70 cases finished the trial and were included into the per protocol set(PPS).2 Baseline data.There were no significant statistical difference between the two groups in age,course of disease,body mass index,number of IVF-ET/ICSI failures,semen volume,sperm density,PR grade sperm,PR+NP grade sperm,the TCM symptom standard score(P>0.05).3 Clinical curative effect3.1 Semen volumeThere was no PR grade sperm difference in the semen volume between the two groups after4-,8-and 12-week treatment(P>0.05).3.2 Sperm density.Compared with pre-treatment 8.24 ± 2.23,there was no statistical difference in the change of sperm density(X 106/ml)in the treatment group at 4 weeks 7.90 ± 2,63 and 8 weeks 9.80 ±2.14 after treatment(P>0.05);but increased at 12weeks 13.17± 3.12 after treatment(P<0.05).Compared with pre-treatment 8.58± 3.62,the control group showed no statistically significant difference in sperm density at 4 weeks 8.90±3.64,8 weeks 9.16 ± 4.08,12 weeks 9.67± 3.33 after treatment(P>0.05).3.3 PR grade spermIn the pre-treatment,4th week and the 8th week,the percentages of PR grade sperm of the experimental group were 10.49±7.37,10.63±6.67 and 14.49±6.99 respectively.There was no statistically significant difference as compared with the previous treatment(P>0.05).In the 12th week,the percentage of PR grade sperm of the experimental group was 19.65±6.50.There was statistically significant difference as compared with the previous treatment(P<0.05).As to the control group,the PR grade sperm of the pre-treatment,4th,8th and 12th week was 10.25±6.66,9.78±5.35,12.80±5.39 and 16.40 ±5.87 respectively.After the 12th week treatment,there was statistical difference compared with baseline value(P<0.05)showing improvement in PR grade sperm.As compared with the control group,the experimental group showed no statistical difference PR grade sperm during 4th and 8th week(P>0.05),but after 12th week treatment,it showed greater improvement than the control group(P<0.05).3.4 PR+NP grade spermIn the pre-treatment,4th week and the 8th week,the percentages of PR+NP grade sperm of the experimental group were 17.98±9.55,19.05±8.52 and 25.94±8.57 respectively.There was no statistically significant difference as compared with the previous treatment(P>0.05).In the 12th week,the percentage of PR+NP grade sperm of the experimental group was 33.79=7.39.There was statistically significant difference as compared with the previous treatment(P<0.05).As to the control group,the PR+NP grade sperm of the pre-treatment,4th,8th and 12th week was 15.27±6.93,18.92 ± 7.22,22.80 ± 6.54,27.00±7.17 respectively.After the 12th week treatment,there was statistical difference as compared with baseline value(P<0.05)showing improvement in PR+NP grade sperm.As compared with the control group,the experimental group showed no statistical difference about PR+NP grade sperm at 4th and 8th week(P>0.05),but after 12th week treatment it showed greater improvement than the control group(P<0.05).3.5 TCM symptom standard scoreTCM symptom scores of the experimental group were 18.43 ± 1.31,12.54 ± 1.17,9.00 ± 1.44,5.74 ± 1.17 respectively after 0-,4-,8-and 12-week of treatment,which were significantly lower than those previous treatment(P<0.05).The TCM symptom scores of the control group were1 8.49± 1.38,18.71 ± 1.78,18.37± 1.72 and 17.86 ± 1.68 respectively.There was no statistical difference between the timings in the control group(P>0.05).3.6 Clinical pregnancy rateAs of the end of follow-up,the total clinical pregnancy rate of the two groups was 17.14%(12/70),the treatment group was 20.00%(7/35),and the control group was 14.29%(5/35),Z=1.61,P=0.20>0.05.There was no statistically significant difference between the two groups.4 Comparison of safetyAfter taking medicine on an empty stomach,2 patients in the experimental group had mild nausea and loss of appetite,and the symptoms disappeared half an hour after having the meal.In the control group,1 case had mild abdominal distension and 1 case had sparse stool after taking medicine.Because the patients with mild symptoms were able to tolerate it,they did not withdraw from the trial observation.No abnormality was found in blood routine,liver function(ALT,AST),renal function(BUN,CR),urine routine and ECG before and after treatment.Conclusions(1)After 12 weeks of treatment,Chaihuangzanyu Decoction could improve the sperm density,PR grade sperm and PRR+NP grade sperm of male infertility(kidney deficiency and liver depression type)after IVF-ET/ICSI failure.It was superior to levocarnitine oral liquid.It can also reduce the TCM symptom score score.(2)After treatment,Chaihuangzanyu Decoction is safe with no obvious side effects. |
PDF Full Text Request