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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05521295
Other study ID # Shengjing Hospital
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date September 1, 2024

Study information

Verified date September 2022
Source Shengjing Hospital
Contact Fangqing Zhao, Doctor
Phone 15210356144
Email zhfq@biols.ac.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study intends to explore the correlation between cervical microbiome, gut microbiome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.


Recruitment information / eligibility

Status Recruiting
Enrollment 3600
Est. completion date September 1, 2024
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: 1. Infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle; 2. Female age: 20-45 years old; 3. Single frozen-thawed blastocyst Transferred 4. Endometrial thickness =7mm on the day of luteal transformation 5. Written informed consent. Exclusion Criteria: 1. Women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura Presence of autoimmune disease; 2. Untreated hyperprolactinemia, thyroid disease, adrenal disease 3. Antibiotic use within the past 7 days; 4. Current or recent (within 3 months) drug abuse, including alcohol and tobacco; 5. Refused or unable to comply with protocol requirements; 6. Participation in any experimental drug study within 60 days prior to screening.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention in this study

Locations

Country Name City State
China Xiuxia Wang Shenyang Liaoning

Sponsors (2)

Lead Sponsor Collaborator
Shengjing Hospital Beijing Institutes of Life Science, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Conception Concentration of serum human chorionic gonadotropin =10 mIU/mL 09.01.2022 to 09.01.2024
Secondary Clinical pregnancy detection of a gestational sac in the uterine cavity 3 weeks after conception 09.01.2022 to 09.01.2024
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