Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome

NCT ID: NCT05521295

Last Updated: 2022-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility Microbiome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Conception positive

serum human chorionic gonadotropin ≥10 mIU/mL

no intervention

Intervention Type OTHER

no intervention in this study

Conception negative

serum human chorionic gonadotropin \<10 mIU/mL

no intervention

Intervention Type OTHER

no intervention in this study

Interventions

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no intervention

no intervention in this study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Institutes of Life Science, Chinese Academy of Sciences

UNKNOWN

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiuxia Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiuxia Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Center of Reproductive Medicine, Shengjing Hospital of China Medical University

Donghua Cao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shengyang Jinghua Hospital Co.,Ltd

Sufen Cai, Doctor

Role: PRINCIPAL_INVESTIGATOR

Reproductive and Genetic Hospital of CITIC-Xiangya

Yanwen Xu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Reproductive Medical Center, the First Affiliated Hospital, Sun Yat-sen University

Hong Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

Center of reproduction and genetics Suzhou Municipal Hospital

Locations

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Xiuxia Wang

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fangqing Zhao, Doctor

Role: CONTACT

15210356144

Facility Contacts

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Xiuxia Wang

Role: primary

18940251898

Other Identifiers

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Shengjing Hospital

Identifier Type: -

Identifier Source: org_study_id

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