Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521295
• Other study ID #: Shengjing Hospital
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2022
• Source: Shengjing Hospital
• Contact: Fangqing Zhao, Doctor
• Phone: 15210356144
• Email: zhfq[@]biols.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3600
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Microbiome

Intervention

Other:
• no intervention
no intervention in this study

Locations

Country	Name	City	State
China	Xiuxia Wang	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Shengjing Hospital	Beijing Institutes of Life Science, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conception	Concentration of serum human chorionic gonadotropin =10 mIU/mL	09.01.2022 to 09.01.2024
Secondary	Clinical pregnancy	detection of a gestational sac in the uterine cavity 3 weeks after conception	09.01.2022 to 09.01.2024