Pregnant WomenNCT04848571
Effects of Chinese Medicine on Early Pregnant Women
An observational study of Pregnant Women, run by Shanghai Meiji Health Science and Technology Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Fetal Protection Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 2 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 17 patients in contol group and 28 patients in the Chinaese medicine intervention group
Who may be able to join
- recieved IVF
- childbirth without miscarriage
- taking vitamins during pregnancy
Who cannot join
- miscarrige
- missed sampling in the fourth week of pregnancy
- not appropriate judged by the doctor
Trial locations and contacts
1 site in 1 country.
China1 site
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai
About this study
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.
Read the 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.
- Conditions
- Pregnant Women
- Being tested
- Fetal Protection Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Protection PillCombination product
A Chinese medicine used in pregnant women for fetal protection, including mainly Rehmannia glutinosa.
| Study group | Role | What they receive |
|---|---|---|
| control group | Pregnant women who received IVF and not taken Chinesene fetal protection medicine until sampling | |
| medicine group | Pregnant women who received IVF and have taken Chinesene fetal protection medicine from the fourth week during early pregnancy Receives: Combination Product: Fetal Protection Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
16s DNA analysis in feces
intestinal flora analysis in patients
Measured: the fourth week in early pregnancy
Secondary outcomes (1)
plasma metabonomics analysis by GC/LC mass
plasma metabolic analysis in patients
Measured: the fourth week in early pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 May 2021
- Primary completion1 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Meiji Health Science and Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Institute of Planned Parenthood Research
- Responsible party
- Sponsor
- Investigators
- Enuo Liu, Dr., Study chair, Shanghai Institute of Planned Parenthood Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848571
- Sponsor's protocol ID
- sippr
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2021
- Last updated
- 17 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chinese Medicine on Early Pregnant Women
- ClinicalTrials.gov ID
- NCT04848571
- Acronym / sponsor ID
- sippr
- Conditions
- Pregnant Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shanghai Meiji Health Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Institute of Planned Parenthood Research
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –Pregnant women who received IVF and not taken Chinesene fetal protection medicine until sampling |
| medicine group | – | Combination Product: Fetal Protection PillPregnant women who received IVF and have taken Chinesene fetal protection medicine from the fourth week during early pregnancy |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 17 patients in contol group and 28 patients in the Chinaese medicine intervention group
Key inclusion criteria (3 listed)
- recieved IVF
- childbirth without miscarriage
- taking vitamins during pregnancy
Key exclusion criteria (3 listed)
- miscarrige
- missed sampling in the fourth week of pregnancy
- not appropriate judged by the doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Protection PillA Chinese medicine used in pregnant women for fetal protection, including mainly Rehmannia glutinosa. | Combination product | medicine group |
Primary outcome
16s DNA analysis in feces
Time frame: the fourth week in early pregnancy
intestinal flora analysis in patients
1 secondary outcome
plasma metabonomics analysis by GC/LC mass
Time frame: the fourth week in early pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enuo Liu, Dr. study chair
Shanghai Institute of Planned Parenthood Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women, run by Shanghai Meiji Health Science and Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16s DNA analysis in feces (time frame: the fourth week in early pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.