Pregnant Women Clinical Trial
Official title:
Effects of Chinese Medicine on Early Pregnant Women
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 |
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Meiji Health Science and Technology Co., Ltd. | Shanghai Institute of Palnned parenthood research |
China,
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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