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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04848571
Other study ID # sippr
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date November 2, 2021

Study information

Verified date May 2024
Source Shanghai Meiji Health Science and Technology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

From April 2021 to December 2021, 50 pregnant women who received intro fertilization (IVF) will be recuited. Among them, 25 of them would like to take Chinese medicine from the 2nd week after embryo transfer (intervention group), while the remaining 25 will not intake Chinese medicine (control group). Blood and feces samples will be collected in the early morning of the 4th and 6th week after embryo transfer to detect 16S DNA sequences in feces, plasma metabolites, and whole blood transcriptomics.


Description:

Investigators planned to performed a randomized trial to determine the effects of the Chinese medicine (Bushen Antai recipe) including mainly Rehmannia glutinosa used in pregnant women for fetal protection. Two groups will be recruited, Chinese medicine intervention group and control group without Chinese medicine. In the 4th and 6th week after embryo transfer, blood and fetal are sampling for metabolic and intestinal microbiota analysis.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date November 2, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Fetal Protection Pill
A Chinese medicine used in pregnant women for fetal protection, including mainly Rehmannia glutinosa.

Locations

Country Name City State
China Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Meiji Health Science and Technology Co., Ltd. Shanghai Institute of Palnned parenthood research

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other whole blood transcriptomics analysis by RNA sequencing blood transcriptomic analysis in patients the fourth week in early pregnancy
Primary 16s DNA analysis in feces intestinal flora analysis in patients the fourth week in early pregnancy
Secondary plasma metabonomics analysis by GC/LC mass plasma metabolic analysis in patients the fourth week in early pregnancy
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