Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome

Recruiting

• Conditions: Infertility; Microbiome
• Interventions: Other: no intervention

• Registration Number: NCT05521295
• Lead Sponsor: Shengjing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Status Verified: 2022-09
• Study Start: 2022-09-01
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19
• Primary Completion: 2023-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3600

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conception positive	no intervention	serum human chorionic gonadotropin ≥10 mIU/mL
Conception negative	no intervention	serum human chorionic gonadotropin \<10 mIU/mL

Primary Outcome Measures

Name	Time	Method
Conception	09.01.2022 to 09.01.2024	Concentration of serum human chorionic gonadotropin ≥10 mIU/mL

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy	09.01.2022 to 09.01.2024	detection of a gestational sac in the uterine cavity 3 weeks after conception

Trial Locations

Locations (1)

Xiuxia Wang; 🇨🇳 Shenyang, Liaoning, China