Effects of Chinese Medicine on Early Pregnant Women

NCT ID: NCT04848571

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-11-02

Brief Summary

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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

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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.

Conditions

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Pregnant Women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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control group

Pregnant women who received IVF and not taken Chinesene fetal protection medicine until sampling

No interventions assigned to this group

medicine group

Pregnant women who received IVF and have taken Chinesene fetal protection medicine from the fourth week during early pregnancy

Fetal Protection Pill

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Fetal Protection Pill

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Institute of Palnned parenthood research

UNKNOWN

Sponsor Role collaborator

Shanghai Meiji Health Science and Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enuo Liu, Dr.

Role: STUDY_CHAIR

Shanghai Institute of Planned Parenthood Research

Locations

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Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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sippr

Identifier Type: -

Identifier Source: org_study_id

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