Detection of PCOS by Sensors Array

NCT03046537 | Unknown DMC

• 1 other identifier: 020916COM1k
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Detection of metabolic state of women with polycystic ovary using NA-Nose.

Conditions

Metabolic State, Breath Analysis, NA-Nose

Outcome Measures

Primary Outcomes (1)

• Detection of different metabolic state between groups.

  Finding that there special markers in the breath test that indicate a different metabolic state in PCOS.

  two years

Study Arms (2)

ovulatory

ACTIVE COMPARATOR

Comparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant.

Diagnostic Test: Breath test

PCOS

ACTIVE COMPARATOR

Comparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant

Diagnostic Test: Breath test

Interventions

Breath test DIAGNOSTIC_TEST

Collecting breath test from participants

PCOS; ovulatory

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Interventions

Breath Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ovulatory women will be compared to women who do not ovulate regularly (PCOS)

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 8, 2017
• Study Start: March 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share