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Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome and Transcriptome

Sponsor
Shengjing Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05545631
Collaborator
Beijing Institutes of Life Science, Chinese Academy of Sciences (Other)
300
Enrollment
1
Location
24
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Microbiome and Transcriptome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Conception positive

serum human chorionic gonadotropin ≥10 mIU/mL

Other: no intervention
no intervention in this study
Conception negative

serum human chorionic gonadotropin <10 mIU/mL

Other: no intervention
no intervention in this study

Outcome Measures

Primary Outcome Measures

  1. Concentration of serum human chorionic gonadotropin ≥10 mIU/mL [09.01.2022 to 09.01.2024]

    Conception

Secondary Outcome Measures

  1. Clinical pregnancy [09.01.2022 to 09.01.2024]

    detection of a gestational sac in the uterine cavity 3 weeks after conception

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Female
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xiuxia Wang Shenyang Liaoning China 110001

Sponsors and Collaborators

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

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiuxia Wang, Principal Investigator, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT05545631
Other Study ID Numbers:
  • Shengjing Hospital 1
First Posted:
Sep 19, 2022
Last Update Posted:
Sep 19, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility

Study Results

No Results Posted as of Sep 19, 2022