Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome and Transcriptome
Microbiome and Transcriptome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study
1 other identifier
observational
300
1 country
1
Brief Summary
This study intends to explore the correlation between cervical microbiome, gut microbiome, transcriptome 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedSeptember 19, 2022
September 1, 2022
1 year
September 15, 2022
September 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Concentration of serum human chorionic gonadotropin ≥10 mIU/mL
Conception
09.01.2022 to 09.01.2024
Secondary Outcomes (1)
Clinical pregnancy
09.01.2022 to 09.01.2024
Study Arms (2)
Conception positive
serum human chorionic gonadotropin ≥10 mIU/mL
Conception negative
serum human chorionic gonadotropin \<10 mIU/mL
Interventions
Eligibility Criteria
Patients attending Center of Reproductive Medicine
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiuxia Wang
Shenyang, Liaoning, 110001, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiuxia Wang, Doctor
Center of Reproductive Medicine, Shengjing Hospital of China Medical University
- PRINCIPAL INVESTIGATOR
Sufen Cai, Doctor
Reproductive and Genetic Hospital of CITIC-Xiangya
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 15, 2022
First Posted
September 19, 2022
Study Start
September 1, 2022
Primary Completion
September 1, 2023
Study Completion
September 1, 2024
Last Updated
September 19, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share