Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome

NCT05521295 | Unknown

• 1 other identifier: Shengjing Hospital
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Microbiome

Outcome Measures

Primary Outcomes (1)

• Conception

  Concentration of serum human chorionic gonadotropin ≥10 mIU/mL

  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

Other: no intervention

Conception negative

serum human chorionic gonadotropin \<10 mIU/mL

Other: no intervention

Interventions

no intervention OTHER

no intervention in this study

Conception negative; Conception positive

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

Sponsors & Collaborators

• Shengjing Hospital: lead
• Beijing Institutes of Life Science, Chinese Academy of Sciences: collaborator

Study Sites (1)

Xiuxia Wang

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Xiuxia Wang, Doctor

  Center of Reproductive Medicine, Shengjing Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

• Donghua Cao, Doctor

  Shengyang Jinghua Hospital Co.,Ltd

  PRINCIPAL INVESTIGATOR

• Sufen Cai, Doctor

  Reproductive and Genetic Hospital of CITIC-Xiangya

  PRINCIPAL INVESTIGATOR

• Yanwen Xu, Doctor

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

  PRINCIPAL INVESTIGATOR

• Hong Li, Doctor

  Center of reproduction and genetics Suzhou Municipal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangqing Zhao, Doctor

CONTACT

15210356144; zhfq@biols.ac.cn

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: August 26, 2022
• First Posted: August 30, 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

Locations

CN (1)