Endometrial Receptivity FailureNCT01588223
Non Invasive Diagnostic of Endometrial Receptivity
A study testing Lipid identification in people with Endometrial Receptivity Failure, run by Igenomix at 1 site in Spain.
Trial summary
The purpose of this study is to determine a lipidomic profile on the endometrial fluid, that can predict endometrial receptivity. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Receptivity Failure
- What is being tested?
- Lipid identification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to May 2012
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Oocyte donors undergoing controlled ovarian stimulation
- Regular menstrual cycles
- no abnormal karyotype
- generally healthy
- BMI 19-29 Kg/m2 (both inclusive)
- 18 to 35 years old.
Who cannot join
- -patients diagnosed with endometriosis and/or endometritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non Invasive Diagnostic of Endometrial Receptivity Based on Lipidomic Profile on Endometrial Fluid.
The purpose of this study is to determine a lipidomic profile on the endometrial fluid, that can predict endometrial receptivity.
- Conditions
- Endometrial Receptivity Failure
- Being tested
- Lipid identification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid identificationOther
The lipids are identified using Mass Spectrometry
| Study group | Role | What they receive |
|---|---|---|
| Lipids | Experimental | Not described Receives: Other: Lipid identification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of lipids in the endometrial fluid as a diagnostic factor.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Receptivity FailureStudies 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igenomix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588223
- Sponsor's protocol ID
- 1002-C-069-OB
- Status last verified
- Mar 2014
- First submitted
- 26 Apr 2012
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non Invasive Diagnostic of Endometrial Receptivity Based on Lipidomic Profile on Endometrial Fluid.
- ClinicalTrials.gov ID
- NCT01588223
- Acronym / sponsor ID
- 1002-C-069-OB
- Conditions
- Endometrial Receptivity Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IgenomixIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Apr 2012 (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 determine a lipidomic profile on the endometrial fluid, that can predict endometrial receptivity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipids | Experimental | Other: Lipid identification |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Oocyte donors undergoing controlled ovarian stimulation
- Regular menstrual cycles
- no abnormal karyotype
- generally healthy
- BMI 19-29 Kg/m2 (both inclusive)
Key exclusion criteria (1 listed)
- -patients diagnosed with endometriosis and/or endometritis.
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 |
|---|---|---|
| Lipid identificationThe lipids are identified using Mass Spectrometry | Other | Lipids |
Primary outcome
Levels of lipids in the endometrial fluid as a diagnostic factor.
Time frame: 1 year
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 27 Mar 2014.
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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 Lipid identification in people with Endometrial Receptivity Failure, run by Igenomix at 1 site in Spain.
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 6 inclusion and 1 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 27 Mar 2014. 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 Spain. 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?
Levels of lipids in the endometrial fluid as a diagnostic factor. (time frame: 1 year). 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 27 Mar 2014.