Effects of Chinese Medicine on Early Pregnant Women

June 13, 2025 updated by: Shanghai Meiji Health Science and Technology Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

17 patients in contol group and 28 patients in the Chinaese medicine intervention group

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Combination product: Fetal Protection Pill
A Chinese medicine used in pregnant women for fetal protection, including mainly Rehmannia glutinosa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
16s DNA analysis in feces
Time Frame: the fourth week in early pregnancy
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
Time Frame: the fourth week in early pregnancy
plasma metabolic analysis in patients
the fourth week in early pregnancy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
whole blood transcriptomics analysis by RNA sequencing
Time Frame: the fourth week in early pregnancy
blood transcriptomic analysis in patients
the fourth week in early pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Meiji Health Science and Technology Co., Ltd.

Collaborators

Shanghai Institute of Palnned parenthood research

Investigators

  • Study Chair: Enuo Liu, Dr., Shanghai Institute of Planned Parenthood Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

November 2, 2021

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • sippr

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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