Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05521295

Enrollment

3600

Registered

2022-08-30

Start date

2022-09-01

Completion date

2024-09-01

Last updated

2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Microbiome

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.

Interventions

OTHERno intervention

no intervention in this study

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Conception	09.01.2022 to 09.01.2024	Concentration of serum human chorionic gonadotropin ≥10 mIU/mL

Secondary

Measure	Time frame	Description
Clinical pregnancy	09.01.2022 to 09.01.2024	detection of a gestational sac in the uterine cavity 3 weeks after conception

Countries

China

Contacts

Primary ContactFangqing Zhao, Doctor

zhfq@biols.ac.cn15210356144

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026