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Effects of Chinese Medicine on Early Pregnant Women

Effects of Chinese Medicine on Early Pregnant Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04848571
Enrollment
45
Registered
2021-04-19
Start date
2021-05-01
Completion date
2021-11-02
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant Women

Brief summary

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.

Detailed description

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.

Interventions

COMBINATION_PRODUCTFetal Protection Pill

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
16s DNA analysis in fecesthe fourth week in early pregnancyintestinal flora analysis in patients

Secondary

MeasureTime frameDescription
plasma metabonomics analysis by GC/LC massthe fourth week in early pregnancyplasma metabolic analysis in patients

Other

MeasureTime frameDescription
whole blood transcriptomics analysis by RNA sequencingthe fourth week in early pregnancyblood transcriptomic analysis in patients

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026