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临床试验/NCT04848571
NCT04848571已完成不适用

Effects of Chinese Medicine on Early Pregnant Women

Shanghai Meiji Health Science and Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
16s DNA analysis in feces

研究概览

简要总结

From April 2021 to December 2021, 45 pregnant women who received intro fertilization-embyro transfer (IVF-ET) were recuited. According to their own wishes, 28 of them took Chinese medicine from the 2nd week after embryo transfer (intervention group), while the remaining 17 did not intake Chinese medicine (control group). Blood and feces samples were collected in the early morning of the 4th week after embryo transfer to detect 16S DNA sequences in feces, plasma metabolites, and whole blood transcriptomics.

详细描述

Investigators planned to performed a observational clinical trial to determine the effects of the Chinese medicine (Gushen Antai recipe) including mainly Rehmannia glutinosa used in pregnant women for fetal protection. Two groupswere recruited, Chinese medicine intervention group and control group without Chinese medicine. In the 4th week after embryo transfer, blood and fetal were sampled for metabolic and intestinal microbiota analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • recieved IVF
  • childbirth without miscarriage
  • taking vitamins during pregnancy

排除标准

  • miscarrige
  • missed sampling in the fourth week of pregnancy
  • not appropriate judged by the doctor

结局指标

主要结局

16s DNA analysis in feces

时间窗: the fourth week in early pregnancy

intestinal flora analysis in patients

次要结局

  • plasma metabonomics analysis by GC/LC mass(the fourth week in early pregnancy)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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