Status unknownNCT05545631Updated Sep 19, 2022

Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome and Transcriptome

An observational study in Infertility and Microbiome, sponsored by Shengjing Hospital. Status unknown at 1 site in China. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-09-19.

Sponsored by Shengjing Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 300
Ages: 20 Years to 45 Years
Sex: Female

Study 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.

Conditions studied

Infertility
Microbiome

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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 714 observational studies indexed under Infertility.

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Lead sponsor

Shengjing Hospital is the lead sponsor of 124 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 45 Years
Sexes eligible: Female
Sampling method: Probability sample

Study population

Patients attending Center of Reproductive Medicine

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 300 participants (estimated)
Patient registry: No

Groups and cohorts

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

Otherno intervention
no intervention in this study

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

Xiuxia Wang
Shenyang, Liaoning 110001, China
- Xiuxia Wang · Contact · wangxxsj@sina.cn · 18940251898
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05545631
Lead sponsor: Shengjing Hospital
Collaborators: Beijing Institutes of Life Science, Chinese Academy of Sciences
Responsible party: Xiuxia Wang (Principal Investigator, Shengjing Hospital) — Principal investigator
First posted: Sep 19, 2022
Start date: Sep 1, 2022
Primary completion: Sep 1, 2023 (estimated)
Completion: Sep 1, 2024 (estimated)
Last update: Sep 19, 2022

Study contacts

Fangqing Zhao, Doctor

Contact

zhfq@biols.ac.cn

15210356144

Xiuxia Wang, Doctor

principal investigator · Center of Reproductive Medicine, Shengjing Hospital of China Medical University

Sufen Cai, Doctor

principal investigator · Reproductive and Genetic Hospital of CITIC-Xiangya

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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