MicroRNA in Endometrial FluidmiRNA_EFNCT02554539
Transciptomic Modification Induced by miRNAs in Endometrial Fluid
A study testing Endometrial fluid aspiration in people with MicroRNA in Endometrial Fluid, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to understand the mechanism of communication between the uterine environment and the preimplantation human embryo. The investigators are interested in understanding how the in-utero environment during the window of implantation is different in normal weight and overweight/obese women and… Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- MicroRNA in Endometrial Fluid
- What is being tested?
- Endometrial fluid aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 1 Jul 2017
- Phase
- Interventional
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meet the WHO criteria for normal weight (BMI < 25) and overweight/obese (BMI > 25)
- Age 21-45
Who cannot join
- Age < 21 or > 45
- Women with history of hysterectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Embryonic Transciptomic Modification Induced by miRNAs Secreted by Human Endometrium to Endometrial Fluid
The purpose of this study is to understand the mechanism of communication between the uterine environment and the preimplantation human embryo. The investigators are interested in understanding how the in-utero environment during the window of implantation is different in normal weight and overweight/obese women and how this may impact the programming of the developing embryo.
- Conditions
- MicroRNA in Endometrial Fluid
- Being tested
- Endometrial fluid aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial fluid aspirationProcedure or surgery
Patient will undergo a biopsy to aspirate endometrial fluid from the uterine cavity
| Study group | Role | What they receive |
|---|---|---|
| Obese | Experimental | Women, aged 21-45 with BMI >30 Receives: Procedure: Endometrial fluid aspiration |
| Normal weight | Experimental | Women, aged 21-45 with BMI < 25 Receives: Procedure: Endometrial fluid aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression profile in human embryos
We will perform RNA sequencing on the human embryo to quantify which genes are up and down regulated in obese compared to normal weight controls.
Measured: Samples will be collected within 1 month of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start1 Jul 2015
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroRNA in Endometrial FluidStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meera Sridhar Shah, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554539
- Sponsor's protocol ID
- 34225
- Acronym
- miRNA_EF
- Status last verified
- Apr 2018
- First submitted
- 27 Aug 2015
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Embryonic Transciptomic Modification Induced by miRNAs Secreted by Human Endometrium to Endometrial Fluid
- ClinicalTrials.gov ID
- NCT02554539
- Acronym / sponsor ID
- miRNA_EF / 34225
- Conditions
- MicroRNA in Endometrial Fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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.
The purpose of this study is to understand the mechanism of communication between the uterine environment and the preimplantation human embryo. The investigators are interested in understanding how the in-utero environment during the window of implantation is different in normal weight and overweight/obese women and how this may impact the programming of the developing embryo.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | Experimental | Procedure: Endometrial fluid aspirationWomen, aged 21-45 with BMI >30 |
| Normal weight | Experimental | Procedure: Endometrial fluid aspirationWomen, aged 21-45 with BMI < 25 |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meet the WHO criteria for normal weight (BMI < 25) and overweight/obese (BMI > 25)
- Age 21-45
Key exclusion criteria (2 listed)
- Age < 21 or > 45
- Women with history of hysterectomy
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 |
|---|---|---|
| Endometrial fluid aspirationPatient will undergo a biopsy to aspirate endometrial fluid from the uterine cavity | Procedure or surgery | Normal weight, Obese |
Primary outcome
Gene expression profile in human embryos
Time frame: Samples will be collected within 1 month of enrollment
We will perform RNA sequencing on the human embryo to quantify which genes are up and down regulated in obese compared to normal weight controls.
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 20 Apr 2018.
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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 study testing Endometrial fluid aspiration in people with MicroRNA in Endometrial Fluid, run by Stanford University at 1 site in United States.
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 2 inclusion and 2 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 20 Apr 2018. 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 United States. 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?
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?
Gene expression profile in human embryos (time frame: Samples will be collected within 1 month of enrollment). 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 20 Apr 2018.