Effects of Chinese Medicine on Early Pregnant Women

NCT04848571 | Completed

• 1 other identifier: sippr
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (1)

• 16s DNA analysis in feces

  intestinal flora analysis in patients

  the fourth week in early pregnancy

Secondary Outcomes (1)

• plasma metabonomics analysis by GC/LC mass

  the fourth week in early pregnancy

Other Outcomes (1)

• whole blood transcriptomics analysis by RNA sequencing

  the fourth week in early pregnancy

Study Arms (2)

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

Interventions

Fetal Protection Pill COMBINATION_PRODUCT

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

medicine group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• recieved IVF
• childbirth without miscarriage
• taking vitamins during pregnancy

You may not qualify if:

• miscarrige
• missed sampling in the fourth week of pregnancy
• not appropriate judged by the doctor

Sponsors & Collaborators

• Shanghai Meiji Health Science and Technology Co., Ltd.: lead
• Shanghai Institute of Palnned parenthood research: collaborator

Study Sites (1)

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, China

Location

Study Officials

• Enuo Liu, Dr.

  Shanghai Institute of Planned Parenthood Research

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 19, 2021
• Study Start: May 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 2, 2021
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)