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典型文献
Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age:A Multicenter,Randomized,Double-Blind,Placebo-Controlled Trial
文献摘要:
Objective:To evalvate efficacy of Qizi Yusi Pills(QYP),a Chinese medicine compound preparation,on in vitro fertilization-embryo transfer(IVF-ET)in women of advanced reproductive age.Methods:This multicenter,randomized,double-blind,placebo-controlled trial was conducted from June 2018 to October 2019.A total of 124 patients were randomly allocated to either the QYP group or the placebo group using a stratified block randomization design,with 62 patients in each group.All patients completed controlled ovarian stimulation using a standard gonadotropin-releasing hormone agonist(GnRH-a)long protocol.As the QYP group,QYP was administered while the control group received placebo.QYP and placebo were administered for a total of 24 to 30 days from the day of GnRH-a pituitary downregulation to transvaginal oocyte retrieval.Both medications were taken orally at doses of 10 g three times each day.The primary outcome was cumulative pregnancy rate,and the secondary outcomes were periodic medication,follicular status,serum hormone and endometrial receptivity.Follow-up continued until 4 weeks after delivery.Maternal and neonatal complications,such as gestational diabetes,were also observed.Results:Overall,119 patients completed the study,60 in the QYP group and 59 in the placebo group.Per protocol(PP)analysis revealed that 6-month cumulative pregnancy rate in the QYP group was significantly higher than that in the placebo group[43.33%(26/60)vs.25.42%(15/59),P=0.040).Additionally,more oocytes were retrieved from the QYP group than those from the placebo group(8.95±3.12 vs.7.85±1.91,P=0.022).Moreover,the endometrial thickness of HCG day in the QYP group was significantly higher than that in the placebo group(11.78±2.27 mm vs.10.68±2.07 mm,P=0.012).Maternal and neonatal complications between the two groups were not significantly different(P>0.05).Intention-to-treat analysis was in line with PP results.Conclusions:QYP can enhance ovarian reserve capacity and ovarian response,and possibly promote endometrial receptivity.QYP effectively improves cumulative pregnancy rates in older patients(≥35 years)undergoing IVF-ET.(Registration No.ChiCTR1 800014427)
文献关键词:
作者姓名:
ZHANG Yi;QIAO Yan;Li Li;GAO Dan-dan;SONG Jing-yan;SUN Zhen-gao
作者机构:
College of Traditional Chinese Medicine,Shandong University of Traditional Chinese Medicine,Jinan(250355),China;The First Clinical College,Shandong University of Traditional Chinese Medicine,Jinan(250014),China;Reproductive and Genetic Center of Integrated Medicine,The Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan(250011),China
引用格式:
[1]ZHANG Yi;QIAO Yan;Li Li;GAO Dan-dan;SONG Jing-yan;SUN Zhen-gao-.Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age:A Multicenter,Randomized,Double-Blind,Placebo-Controlled Trial)[J].中国结合医学杂志(英文版),2022(08):675-682
A类:
Qizi,Yusi,evalvate,QYP,ChiCTR1
B类:
Efficacy,Pregnancy,Outcomes,Women,Advanced,Reproductive,Age,Multicenter,Randomized,Double,Blind,Placebo,Controlled,Trial,Objective,To,efficacy,Pills,Chinese,medicine,compound,preparation,vitro,fertilization,embryo,transfer,IVF,ET,women,advanced,reproductive,age,Methods,This,multicenter,randomized,double,blind,placebo,controlled,was,conducted,from,June,October,total,patients,were,randomly,allocated,either,using,stratified,block,randomization,design,each,All,completed,ovarian,stimulation,standard,gonadotropin,releasing,hormone,agonist,GnRH,long,protocol,administered,while,received,days,pituitary,downregulation,transvaginal,retrieval,Both,medications,taken,orally,doses,three,times,primary,cumulative,pregnancy,secondary,outcomes,periodic,follicular,status,serum,endometrial,receptivity,Follow,continued,until,weeks,after,delivery,Maternal,neonatal,complications,such,gestational,diabetes,also,observed,Results,Overall,study,Per,PP,analysis,revealed,that,month,significantly,higher,than,Additionally,more,oocytes,retrieved,those,Moreover,thickness,HCG,between,two,groups,not,different,Intention,treat,line,results,Conclusions,enhance,reserve,capacity,response,possibly,promote,effectively,improves,rates,older,years,undergoing,Registration,No
AB值:
0.527334
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