妇宝当归胶对IVF反复种植失败患者冻融胚胎移植结局影响的初步研究

目的:评价妇宝当归胶在改善反复种植失败患者妊娠结局中的应用价值。方法:本研究为前瞻性、开放性随机对照试验(Randomized Controlled Trial,RCT),59名反复种植失败(Recurrent Implantation Failure,RIF)患者皆行人工周期冻融胚胎移植(Frozen Embryo Transfer,FET),共分为两组,干预组采用人工周期配合妇宝当归胶进行内膜准备,对照组仅采用人工周期方案。统计学上采用独立样本T检验、Mann–Whitney U检验和Chi-square分析,P<0.05为差异有统计学意义。结果:中医证候积分比较,治疗组显著低于对照组(P<0.05);与对照组相比,干预组内膜转化日子宫内膜血管化指数(Vascularization Index,VI)(P=0.001)、血管血流指数(Vascularization Flow Index,VFI)(P=0.003)更高,差异具有统计学意义;两组白细胞介素17(Interleukin 17,IL-17)水平比较有显著性差异(P<0.01),治疗组低于对照组。同时,FET后干预,差异具有统计学意义41.4%(12/29)vs 16.7%(5/30);31%(9/29)vs 10%(3/30);31%(9/29)vs 6.7%(2/30)。结论:妇宝当归胶可通过改善子宫内膜容受性(Endometrial Receptivity,ER),增加RIF患者持续妊娠率、临床妊娠率及阳性妊娠率,改善其IVF/ICSI妊娠结局,其机制可能与改善子宫内膜血流,调整子宫内膜局部免疫等功能有关。由于本次研究为开放性预试验,受样本量和盲法的限制,结果可能存在一定程度偏倚,因此其疗效仍需要更多的多中心、大样本、双盲RCT验证。

Fubao DangguiJiao improves endometrium receptivity in women withrecurrent implantation failure undergoing IVF : a pilot study

Objective To evaluate the application value of the Fubao Dangguijiao(妇宝当归胶)in improving the pregnancy outcome of recurrent implantation failure.Method This study is a prospective,open randomized controlled trials(RCT).59 patients with recurrent implantation failure(RIF)had artificial cycle of frozen embryo transfer(FET),which is divided into two groups intervention group using artificial cycle with Fubao Dangguijiao for endometrial preparation,the control group using artificial cycle.Student’s t-test for independent samples,Mann–Whitney U-test and Chi-square analysis were used where appropriate.Differences were considered significant if(P<0.05).Result Comparison of the points of TCM syndrome in two groups,the treatment group was lower than the control group(P<0.05).Compared with the control group,the endometrium vascularization index VI(P=0.001)and vascular blood flow index VFI(P=0.003)were higher in the intervention group,and the difference was statistically significant.In peripheral blood IL-7 level,the intervention group was lower than the control group,and the difference was statistically significant(P<0.01).Meanwhile,PPR,CPR and OPR in the post-FET intervention group were severally higher than the control group,and the difference was statistically significant 41.4%(12/29)vs 16.7%(5/30);31%(9/29)vs 10%(3/30);31%(9/29)vs6.7%(2/30).Conclusion By improving the endometrial receptivity and reducing the rate of pregnancy loss in RIF patients,it can enhance the ongoing pregnancy rate,clinical pregnancy rate and positive pregnancy rate,and ameliorate the pregnancy outcome of IVF/ICSI.As this study is an open pilot study,limited by the sample size and the blind method,the result may have a certain degree of bias.Therefore,more multi-center,large sample and double-blind RCT validation are needed for the efficacy.