Microbiome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study

Shengjing Hospital1 site in 1 country3,600 target enrollmentSeptember 1, 2022

ConditionsInfertility Microbiome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infertility
Sponsor: Shengjing Hospital
Enrollment: 3600
Locations: 1
Primary Endpoint: Conception
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

September 1, 2024

Last Updated

3 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Shengjing Hospital

Responsible Party

Principal Investigator

Xiuxia Wang

Principal Investigator

Shengjing Hospital

Eligibility Criteria

Inclusion Criteria

•Infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle;
•Female age: 20-45 years old;
•Single frozen-thawed blastocyst Transferred
•Endometrial thickness ≥7mm on the day of luteal transformation
•Written informed consent.

Exclusion Criteria

•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;
•Untreated hyperprolactinemia, thyroid disease, adrenal disease
•Antibiotic use within the past 7 days;
•Current or recent (within 3 months) drug abuse, including alcohol and tobacco;
•Refused or unable to comply with protocol requirements;
•Participation in any experimental drug study within 60 days prior to screening.