Metabolic State, Breath Analysis, NA-NoseNCT03046537
Detection of PCOS by Sensors Array
A study testing Breath test in people with Metabolic State, Breath Analysis, NA-Nose, run by Meir Medical Center.
Trial summary
Detection of metabolic state of women with polycystic ovary using NA-Nose. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic State, Breath Analysis, NA-Nose
- What is being tested?
- Breath test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Mar 2019
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Detection of PCOS and Ovulation Timing by NA-Nose
Detection of metabolic state of women with polycystic ovary using NA-Nose.
Read the detailed description
Breath of women undergoing fertility treatment including PCOS and ovulatory women will be collected and transferred for our labs for further analysis in define the metabolic state. The detection will be made using sensors arrays and GCMS.
- Being tested
- Breath test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath testDiagnostic test
Collecting breath test from participants
| Study group | Role | What they receive |
|---|---|---|
| ovulatory | Active comparator | Comparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant. Receives: Diagnostic Test: Breath test |
| PCOS | Active comparator | Comparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant Receives: Diagnostic Test: Breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of different metabolic state between groups.
Finding that there special markers in the breath test that indicate a different metabolic state in PCOS.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startMar 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic State, Breath Analysis, NA-NoseStudies 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
- Parallel groups
- Model description
- ovulatory women will be compared to women who do not ovulate regularly (PCOS)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046537
- Sponsor's protocol ID
- 020916COM1k
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2017
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of PCOS and Ovulation Timing by NA-Nose
- ClinicalTrials.gov ID
- NCT03046537
- Acronym / sponsor ID
- 020916COM1k
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 8 Feb 2017 (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.
Detection of metabolic state of women with polycystic ovary using NA-Nose.
Detailed description
Breath of women undergoing fertility treatment including PCOS and ovulatory women will be collected and transferred for our labs for further analysis in define the metabolic state. The detection will be made using sensors arrays and GCMS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ovulatory women will be compared to women who do not ovulate regularly (PCOS)
| Arm | Type | Receives |
|---|---|---|
| ovulatory | Active comparator | Diagnostic Test: Breath testComparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant. |
| PCOS | Active comparator | Diagnostic Test: Breath testComparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Breath testCollecting breath test from participants | Diagnostic test | PCOS, ovulatory |
Primary outcome
Detection of different metabolic state between groups.
Time frame: two years
Finding that there special markers in the breath test that indicate a different metabolic state in PCOS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Breath test in people with Metabolic State, Breath Analysis, NA-Nose, run by Meir Medical Center.
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 0 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: status not confirmed, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Detection of different metabolic state between groups. (time frame: two years). 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 14 Feb 2017.