| Purpose and significance:Repeated implantation failure refers to the situation where infertility patients undergo multiple in vitro fertilization or intracytoplasmic sperm injection cycles and transplanted multiple high-quality embryos without embryo implantation or clinical pregnancy.In this study,meta-analysis method was used to summarize the published literature and the ongoing research,to explore the influence of traditional Chinese medicine intervention on the pregnancy outcome of patients with repeated implant failure,in order to provide evidence-based basis for clinical treatment.Methods:We used a computer for literature retrieval,and searched CNKI,VIP,CBM,Wanfang,Pub Med,EMBASE,Cochrane Library,web of science,international clinical trials,open grey,etc.The retrieval period is from the establishment of the database to December 15,2019.The three investigators strictly screened the literature for the inclusion and exclusion criteria of the literature and independently screened the literature for repeated failures in traditional Chinese medicine treatment,and managed the literature using End Note document management software.Cochrane bias risk assessment tool was used to evaluate the methodological quality of the included literature.Rev Man5.3 statistical software was used to perform meta-analysis of the included literature.Results:In this study,270 domestic and foreign literatures related to repeated implant failure were retrieved.After the initial screening of reading titles and abstracts,53 full-text literatures were obtained and read,and 22 literatures met the inclusion and exclusion criteria.Finally,22 clinical randomized controlled trials were quantitatively studied,involving 903 patients in the Chinese medicine treatment group and 898 in the control group.Meta-analysis results show that compared with the control group,the Chinese medicine treatment group has improved pregnancy outcomes: it can improve clinical pregnancy Rate(RR =1.65,95% CI = [1.45,1.87],Z = 7.68,P <0.00001),biochemical pregnancy rate(RR = 1.74,95% CI = [1.39,2.18],Z = 4.85,P <0.00001)and live birth rate(RR = 1.75,95% CI = [1.38,2.21],Z = 4.68,P <0.00001);In terms of improving endometrial conditions: it can increase endometrial thickness on the day of transplantation(SMD = 0.49,95% CI = [0.25,0.73],Z= 3.97,P <0.0001),reduce blood flow parameters of endometrial spiral artery PI(SMD =-0.19,95% CI = [-0.25,-0.13],Z = 6.14,P <0.00001),and RI(SMD =-0.16,95% CI = [-0.18,-0.14],Z = 17.99,P <0.00001));In terms of improving embryo quality: it can reduce the base FSH level(SMD =-0.83,95% CI = [-1.66,0.00],Z = 1.96,P = 0.05)and LH level(SMD =-0.58,95%CI = [-1.03,-0.13],Z = 2.55,P = 0.01),and it can also reduce the amount of Gn(SMD =-0.32,95% CI = [-0.6,-0.03],Z = 2.15,P = 0.03).However,there was no significant difference between the two groups in improving the embryo quality rate(MD =-0.00,95% CI = [-0.13,0.13],z = 0.01,P = 0.99)and reducing the administration time of Gn(SMD =-0.14,95% CI = [-0.61,0.33],z = 0.58,P = 0.56);In terms of safety evaluation: compared with the control group,the Chinese medicine treatment group did not increase the abortion rate(RR = 0.72,95% CI = [0.44,1.20],Z = 1.27,P = 0.21),ectopic pregnancy rate(RR = 0.30,95% CI = [0.06,1.49],Z = 1.47,P = 0.14),and multiple pregnancy rate(MD = 1.05,95% CI = [0.55,1.99],Z = 0.15,P = 0.88)and other adverse risk events.Conclusion:1 Traditional Chinese medicine has a significant clinical effect in treating RIF,which can improve the pregnancy outcome of patients and improve the clinical pregnancy rate,biochemical pregnancy rate and live birth rate of patients with repeated implant failure.2 Traditional Chinese medicine treatment of RIF has certain advantages in improving the endometrial environment,which can increase the thickness of the endometrium and reduce the blood flow parameters PI and RI of the endometrial spiral artery.3 Traditional Chinese medicine treatment of RIF has some advantages in improving ovarian responsiveness and ovarian reserve function,which can reduce the level of basic FSH and LH,and reduce the dosage of GN.However,there is no obvious advantage in shortening the time of using GN.At the same time,traditional Chinese medicine treatment needs further research in improving the number of high-quality embryos.4 Traditional Chinese medicine combined with assisted reproductive technology in the treatment of RIF does not increase the occurrence of adverse risk events such as ectopic pregnancy rate,multiple pregnancy rate and abortion rate.5 This study still has certain limitations,because the inclusion and exclusion criteria of each study are not completely consistent,and the intervention methods of traditional Chinese medicine,basic treatment of Western medicine,treatment course are not completely the same,resulting in some results heterogeneity.In order to identify the source of heterogeneity,sensitivity analysis is further carried out to reduce the heterogeneity,but the research results may deviate from the real value. |
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