FertilityEarly Phase 1NCT06786273
Time Course of Endometrium's Gene Expression Profiles Using Endometrial Tissue and Blood Samples
A Early Phase 1 study testing Small RNA sequencing in people with Fertility, run by Inti Labs at 1 site in Taiwan.
Trial summary
This study aims to investigate whether the expression levels of microRNA (miRNA) in endometrial tissue and blood samples at various time points after ovulation can serve as biomarkers for assessing endometrial receptivity. Read more about this study
- Who is it for?
- Ages 25 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Small RNA sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Mar 2023to 6 Feb 2024
- Phase
- Early Phase 1
- 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 25 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular menstrual cycle of 28-32 days.
- Between 25-38 years old.
- BMI between 18 to 30.
- Endogenous progesterone (P4) level of < 1 ng/mL prior to exogenous progesterone administration
Who cannot join
- Suspected intrauterine abnormality.
- Women who are breastfeeding
- Have a history of pelvic inflammatory disease, reproductive tract-related diseases, sexually transmitted diseases, systemic diseases or endocrine diseases.
- History of major illness.
- Use of hormonal contraceptives or intrauterine devices in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Course of Endometrium's Gene Expression and DNA Methylation Profiles Using Endometrial Tissue and Blood Samples
This study aims to investigate whether the expression levels of microRNA (miRNA) in endometrial tissue and blood samples at various time points after ovulation can serve as biomarkers for assessing endometrial receptivity.
- Conditions
- Fertility
- Being tested
- Small RNA sequencing
- Keywords
- miRNAs, microRNAs, time course, blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small RNA sequencingGenetic
The blood and endometrial tissue samples collected from the study groups will undergo small RNA sequencing to investigate the microRNA expression profiles associated with that phase.
| Study group | Role | What they receive |
|---|---|---|
| P+3 | Other | Women who get their blood drawn and endometrial tissue biopsy taken at 3 days after progesterone administration starts. Receives: Genetic: Small RNA sequencing |
| P+4 | Other | Women who get their blood drawn and endometrial tissue biopsy taken at 4 days after progesterone administration starts. Receives: Genetic: Small RNA sequencing |
| P+5 | Other | Women who get their blood drawn and endometrial tissue biopsy taken at 5 days after progesterone administration starts. Receives: Genetic: Small RNA sequencing |
| P+6 | Other | Women who get their blood drawn and endometrial tissue biopsy taken at 6 days after progesterone administration starts. Receives: Genetic: Small RNA sequencing |
| P+7 | Other | Women who get their blood drawn and endometrial tissue biopsy taken at 7 days after progesterone administration starts. Receives: Genetic: Small RNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA expression profiles
The samples collected would undergo small RNA sequencing in order to investigate the miRNA expression profiles of the patients and differences in expression profiles between the different intervention groups.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start31 Mar 2023
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inti Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786273
- Sponsor's protocol ID
- CS2-22033
- Status last verified
- Dec 2024
- First submitted
- 15 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course of Endometrium's Gene Expression and DNA Methylation Profiles Using Endometrial Tissue and Blood Samples
- ClinicalTrials.gov ID
- NCT06786273
- Acronym / sponsor ID
- CS2-22033
- Conditions
- Fertility
- Keywords
- miRNAs, microRNAs, time course, blood
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Inti LabsIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 22 Jan 2025 (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 aims to investigate whether the expression levels of microRNA (miRNA) in endometrial tissue and blood samples at various time points after ovulation can serve as biomarkers for assessing endometrial receptivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| P+3 | Other | Genetic: Small RNA sequencingWomen who get their blood drawn and endometrial tissue biopsy taken at 3 days after progesterone administration starts. |
| P+4 | Other | Genetic: Small RNA sequencingWomen who get their blood drawn and endometrial tissue biopsy taken at 4 days after progesterone administration starts. |
| P+5 | Other | Genetic: Small RNA sequencingWomen who get their blood drawn and endometrial tissue biopsy taken at 5 days after progesterone administration starts. |
| P+6 | Other | Genetic: Small RNA sequencingWomen who get their blood drawn and endometrial tissue biopsy taken at 6 days after progesterone administration starts. |
| P+7 | Other | Genetic: Small RNA sequencingWomen who get their blood drawn and endometrial tissue biopsy taken at 7 days after progesterone administration starts. |
Who may qualify
- Ages
- 25 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Regular menstrual cycle of 28-32 days.
- Between 25-38 years old.
- BMI between 18 to 30.
- Endogenous progesterone (P4) level of < 1 ng/mL prior to exogenous progesterone administration
Key exclusion criteria (5 listed)
- Suspected intrauterine abnormality.
- Women who are breastfeeding
- Have a history of pelvic inflammatory disease, reproductive tract-related diseases, sexually transmitted diseases, systemic diseases or endocrine diseases.
- History of major illness.
- Use of hormonal contraceptives or intrauterine devices in the past 3 months.
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 |
|---|---|---|
| Small RNA sequencingThe blood and endometrial tissue samples collected from the study groups will undergo small RNA sequencing to investigate the microRNA expression profiles associated with that phase. | Genetic | P+3, P+4, P+5, P+6, P+7 |
Primary outcome
miRNA expression profiles
Time frame: 1 month
The samples collected would undergo small RNA sequencing in order to investigate the miRNA expression profiles of the patients and differences in expression profiles between the different intervention groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Small RNA sequencing in people with Fertility, run by Inti Labs at 1 site in Taiwan.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jan 2025. 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 Taiwan. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA expression profiles (time frame: 1 month). 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 22 Jan 2025.