InfertilityNCT05545631
Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome and Transcriptome
An observational study of Infertility and Microbiome, run by Shengjing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility, Microbiome
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Adult
Study population: Patients attending Center of Reproductive Medicine
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiuxia Wang
Shenyang, Liaoning, 110001
Xiuxia Wang, 18940251898, wangxxsj@sina.cn
About this study
Official title: Microbiome and Transcriptome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study
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
- Infertility, Microbiome
- Being tested
- no intervention
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| Conception positive | serum human chorionic gonadotropin ≥10 mIU/mL Receives: Other: no intervention | |
| Conception negative | serum human chorionic gonadotropin <10 mIU/mL Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of serum human chorionic gonadotropin ≥10 mIU/mL
Conception
Measured: 09.01.2022 to 09.01.2024
Secondary outcomes (1)
Clinical pregnancy
detection of a gestational sac in the uterine cavity 3 weeks after conception
Measured: 09.01.2022 to 09.01.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Principal investigator, Xiuxia Wang, Shengjing Hospital
- Investigators
- Xiuxia Wang, Doctor, Principal investigator, Center of Reproductive Medicine, Shengjing Hospital of China Medical UniversitySufen Cai, Doctor, Principal investigator, Reproductive and Genetic Hospital of CITIC-Xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545631
- Sponsor's protocol ID
- Shengjing Hospital 1
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome and Transcriptome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05545631
- Acronym / sponsor ID
- Shengjing Hospital 1
- Conditions
- Infertility, Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conception positive | – | Other: no interventionserum human chorionic gonadotropin ≥10 mIU/mL |
| Conception negative | – | Other: no interventionserum human chorionic gonadotropin <10 mIU/mL |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients attending Center of Reproductive Medicine
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention in this study | Other | Conception negative, Conception positive |
Primary outcome
Concentration of serum human chorionic gonadotropin ≥10 mIU/mL
Time frame: 09.01.2022 to 09.01.2024
Conception
1 secondary outcome
Clinical pregnancy
Time frame: 09.01.2022 to 09.01.2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Microbiome, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangqing Zhao, Doctor (15210356144, zhfq@biols.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of serum human chorionic gonadotropin ≥10 mIU/mL (time frame: 09.01.2022 to 09.01.2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.