Effects of Chinese Medicine on Early Pregnant Women

Meiji Seika Pharma

Status: Completed

Conditions: Pregnant Women

Treatments: Combination Product: Fetal Protection Pill

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04848571

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 2 patient groups

control group

Description:

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

medicine group

Description:

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

Treatment:

Combination Product: Fetal Protection Pill