Effects of Chinese Medicine on Early Pregnant Women

Study Overview
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Brief Summary
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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 fetal protection medicine from the fourth week of pregnancy (experimental group), while the remaining 25 will not (control group). Blood and feces will be collected in the early morning of the 6th week after successful transplantation to detect 16S DNA in feces, plasma metabonomics, and whole blood transcriptomics.

Detailed Description
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Investigators planned to performed a randomized trial to determine the effects of the Chinese medicine used in pregnant women for fetal protection, including mainly radix polygoni multiflori, Rehmannia glutinosa. Two groups will be recruited, 25 pregnant women by IVF without medicine and 25 with the Chinese medicine. In the fourth week, blood, plasma and fetal are sampling for metabolic and intestinal analysis.

Official Title
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Effects of Chinese Medicine on Early Pregnant Women

Conditions
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Pregnant Women

Intervention / Treatment
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* Combination Product: Fetal Protection Pill


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>Pregnant women who received IVF and not taken Chinesene fetal protection medicine until sampling | Combination Product: Fetal Protection Pill<br>* A Chinese medicine used in pregnant women for fetal protection, including mainly radix polygoni multiflori, Rehmannia glutinosa.<br>|
| Experimental: medicine group<br>Pregnant women who received IVF and have taken Chinesene fetal protection medicine from the fourth week during early pregnancy | Combination Product: Fetal Protection Pill<br>* A Chinese medicine used in pregnant women for fetal protection, including mainly radix polygoni multiflori, Rehmannia glutinosa.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16s DNA analysis in feces | intestinal flora analysis in patients | the fourth week in early pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma metabonomics analysis by GC/LC mass | plasma metabolic analysis in patients | the fourth week in early pregnancy |