Objective:To evaluate the efficacy and safety of Chinese medicine(CM)improving pregnancy outcomes after surgery for endometriosis-associated infertility.Methods:A multicenter,randomized,doubleblind placebo parallel co...Objective:To evaluate the efficacy and safety of Chinese medicine(CM)improving pregnancy outcomes after surgery for endometriosis-associated infertility.Methods:A multicenter,randomized,doubleblind placebo parallel controlled clinical trial was designed.A total of 202 patients who had laparoscopy for endometriosis-associated infertility with qi stagnation and blood stasis syndrome were included and randomly divided into the CM treatment group and placebo control group at a ratio of 1:1 using a central block randomization from May 2014 to September 2017,101 patients in each group.The two groups received continuous intervention at 1–5 days after surgery,for 6 menstrual cycles.Before ovulation,the CM group was treated Huoxue Xiaoyi Granule(活血消异颗粒);after ovulation,Bushen Zhuyun Granule(补肾助孕颗粒)was involved.The control group was treated with placebo.Transvaginal ultrasonography was performed every menstrual cycle during the treatment,and female hormone levels in the follicular and luteal phases were measured during the 1 st,3 rd and 6 th menstrual cycles.The analysis was continued until pregnancy.The primary outcomes were clinical pregnancy rate and pregnancy outcome,and the secondary outcomes were follicular development and endometrial receptivity.Safety evaluations were performed before and after treatment.Results:(1)Clinical pregnancy and live birth rates:the clinical pregnancy and live birth rates of the CM group were significantly higher than those of the placebo group[44.6%(45/101)vs.29.7%(30/101),34.7%(35/101)vs.20.8%(21/101),both P<0.05].(2)Follicle development:the incidence of dominant follicles,rate of cumulative cycle ovulation,and rate of cumulative cycle mature follicle ovulation were significantly higher in the CM group than those in the placebo group[93.8%(350/373)vs.89.5%(341/381),80.4%(275/342)vs.69.1%(253/366),65.8%(181/275)vs 56.1%(142/253),P<0.05 or P<0.01]).The incidence of cumulative cycle luteinized unruptured follicle syndrome was significantly lower in the CM group tha展开更多
OBJECTIVE:To investigate the effect of—Xiaoyi Yusi decoction(XYYSD,消异育嗣汤),a Traditional Chinese Medicine(TCM),on in vitro fertilization and embryo transfer(IVF-ET)in patients with endometriosis,and to study the ...OBJECTIVE:To investigate the effect of—Xiaoyi Yusi decoction(XYYSD,消异育嗣汤),a Traditional Chinese Medicine(TCM),on in vitro fertilization and embryo transfer(IVF-ET)in patients with endometriosis,and to study the mechanism underpinning the action.METHODS:Women who underwent IVF-ET were divided into three groups by simple randomization:the treatment(n=32;with TCM treatment),patient(n=28;with endometriosis alone),and control(n=33;with male factor alone)groups.The luteal phase short-acting gonadotropin-releasing hormone agonist prolonged protocol was used in all three groups.To compare the changes in TCM scores and reproductive outcomes before and after TCM intervention in patients with endometriosis,partial least-squares discriminant analysis was used to analyze the follicular fluid samples of each group and screen and compare metabolites using the MetaboA nalyst software.RESULTS:The clinical data indicated that following TCM intervention,kidney deficiency and blood stasis symptom patterns improved dramatically in patients with endometriosis and that their clinical pregnancy rate increased significantly(71.9%vs 57.1%,P<0.05).Metabolomics showed that the two groups of samples were separated before and after TCM intervention.After TCM intervention,the intervention group was close to the control group,indicating that the TCM had a certain effect.Pathway analysis revealed that after TCM intervention,the metabolism of glycerin phospholipid,pyruvate,and citric acid was regulated.CONCLUSIONS:Through the pyruvate and glycerophospholipid metabolism pathways and tricarboxylic acid cycle,the TCM XYYSD successfully improved kidney deficiency and blood stasis symptom pattern,as well as the clinical reproductive outcomes of patients with endometriosis-related infertility.展开更多
基金Supported by the Key Projects of the National Science and Technology Pillar Program during the 12th Five-Year Plan Period(No.2014BAI10B08)
文摘Objective:To evaluate the efficacy and safety of Chinese medicine(CM)improving pregnancy outcomes after surgery for endometriosis-associated infertility.Methods:A multicenter,randomized,doubleblind placebo parallel controlled clinical trial was designed.A total of 202 patients who had laparoscopy for endometriosis-associated infertility with qi stagnation and blood stasis syndrome were included and randomly divided into the CM treatment group and placebo control group at a ratio of 1:1 using a central block randomization from May 2014 to September 2017,101 patients in each group.The two groups received continuous intervention at 1–5 days after surgery,for 6 menstrual cycles.Before ovulation,the CM group was treated Huoxue Xiaoyi Granule(活血消异颗粒);after ovulation,Bushen Zhuyun Granule(补肾助孕颗粒)was involved.The control group was treated with placebo.Transvaginal ultrasonography was performed every menstrual cycle during the treatment,and female hormone levels in the follicular and luteal phases were measured during the 1 st,3 rd and 6 th menstrual cycles.The analysis was continued until pregnancy.The primary outcomes were clinical pregnancy rate and pregnancy outcome,and the secondary outcomes were follicular development and endometrial receptivity.Safety evaluations were performed before and after treatment.Results:(1)Clinical pregnancy and live birth rates:the clinical pregnancy and live birth rates of the CM group were significantly higher than those of the placebo group[44.6%(45/101)vs.29.7%(30/101),34.7%(35/101)vs.20.8%(21/101),both P<0.05].(2)Follicle development:the incidence of dominant follicles,rate of cumulative cycle ovulation,and rate of cumulative cycle mature follicle ovulation were significantly higher in the CM group than those in the placebo group[93.8%(350/373)vs.89.5%(341/381),80.4%(275/342)vs.69.1%(253/366),65.8%(181/275)vs 56.1%(142/253),P<0.05 or P<0.01]).The incidence of cumulative cycle luteinized unruptured follicle syndrome was significantly lower in the CM group tha
基金the National Natural Science Fund Project:A Theoretical Study of Renal Reproduction Based on in vitro Fertilization Follicular Fluid Differential Protein-metabolite Global Regulatory Network(No.81874484)。
文摘OBJECTIVE:To investigate the effect of—Xiaoyi Yusi decoction(XYYSD,消异育嗣汤),a Traditional Chinese Medicine(TCM),on in vitro fertilization and embryo transfer(IVF-ET)in patients with endometriosis,and to study the mechanism underpinning the action.METHODS:Women who underwent IVF-ET were divided into three groups by simple randomization:the treatment(n=32;with TCM treatment),patient(n=28;with endometriosis alone),and control(n=33;with male factor alone)groups.The luteal phase short-acting gonadotropin-releasing hormone agonist prolonged protocol was used in all three groups.To compare the changes in TCM scores and reproductive outcomes before and after TCM intervention in patients with endometriosis,partial least-squares discriminant analysis was used to analyze the follicular fluid samples of each group and screen and compare metabolites using the MetaboA nalyst software.RESULTS:The clinical data indicated that following TCM intervention,kidney deficiency and blood stasis symptom patterns improved dramatically in patients with endometriosis and that their clinical pregnancy rate increased significantly(71.9%vs 57.1%,P<0.05).Metabolomics showed that the two groups of samples were separated before and after TCM intervention.After TCM intervention,the intervention group was close to the control group,indicating that the TCM had a certain effect.Pathway analysis revealed that after TCM intervention,the metabolism of glycerin phospholipid,pyruvate,and citric acid was regulated.CONCLUSIONS:Through the pyruvate and glycerophospholipid metabolism pathways and tricarboxylic acid cycle,the TCM XYYSD successfully improved kidney deficiency and blood stasis symptom pattern,as well as the clinical reproductive outcomes of patients with endometriosis-related infertility.
