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Completed

NCT Number: NCT04848571

Effects of Chinese Medicine on Early Pregnant Women

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.

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Key information

Conditions

Pregnant Women

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Fetal Protection Pill

Combination Product

A Chinese medicine used in pregnant women for fetal protection, including mainly Rehmannia glutinosa.

Primary outcomes

  1. 16s DNA analysis in feces

    Time frame: the fourth week in early pregnancy

    intestinal flora analysis in patients

Secondary outcomes

  1. plasma metabonomics analysis by GC/LC mass

    Time frame: the fourth week in early pregnancy

    plasma metabolic analysis in patients

Other outcomes

  1. whole blood transcriptomics analysis by RNA sequencing

    Time frame: the fourth week in early pregnancy

    blood transcriptomic analysis in patients

Sponsors and collaborators

Lead sponsor

Shanghai Meiji Health Science and Technology Co., Ltd.

Industry

Collaborators

  • Shanghai Institute of Planned Parenthood Research

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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