Polycystic Ovary SyndromeNCT04981275
A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype
An observational study of Polycystic Ovary Syndrome, run by Onegevity Health at 1 site in United States.
Trial summary
The purpose of this research study is to explore the relationship between the gut microbiome and hormone levels in women diagnosed with PCOS and determine whether there are differences in the gut microbiome between women with PCOS and women without PCOS. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2021to 30 Sep 2023
- Phase
- Observational
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women, ages 18-40, living in the USA (except for NY, NJ, RI, MD, SD, ND, or HI), who have not been using hormonal therapy for at least 3 months and without other significant health issues or medications affecting hormones. Women must be previously diagnosed with PCOS or considered Healthy and not currently pregnant or nursing. Women will be referred to the study by their Physician or word of mouth.
Who may be able to join
- Women diagnosed with PCOS or Women who are considered Healthy
- 18-40 years old
- Residing in the USA, except for exclusion states
- Have not been using hormonal therapy for at least 3 months
Who cannot join
- Women using hormonal therapy within the last 3 months
- Diagnosed with other significant health conditions or using medications that will affect hormone levels
- Residing in NY, NJ, MD, RI, ND, SD, or HI
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland
College Park, Maryland, 20742
About this study
The purpose of this research study is to explore the relationship between the gut microbiome and hormone levels in women diagnosed with PCOS and determine whether there are differences in the gut microbiome between women with PCOS and women without PCOS.
Consented, enrolled participants will complete a health questionnaire, complete a fasted blood draw at a local laboratory, and provide a stool, saliva, and vaginal swab sample for comprehensive biomarkers, hormones, metagenomics, and metabolomics analysis.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- No intervention study
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention studyOther
This observational study will only collect data, not provide any intervention to participants.
| Study group | Role | What they receive |
|---|---|---|
| Women with PCOS | Women previously diagnosed with PCOS not using hormonal therapy and without other significant health or endocrine issues Receives: Other: No intervention study | |
| Healthy controls | Women self-identifying as generally healthy, not using hormonal therapy, and without any significant health or endocrine issues Receives: Other: No intervention study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotype differences in vaginal microbiome
Understand phenotypical differences from biological samples comparing women with and without PCOS. Vaginal swabs are to be collected by women and analyzed with metagenomics and metabolomics sequencing.
Measured: Samples to be collected on any day once per participant within 30 days of enrollment
Phenotype differences in gut microbiome
Understand phenotypical differences from biological samples comparing women with and without PCOS. Stool samples are to be collected by women and analyzed with metagenomics sequencing.
Measured: Samples to be collected once on any day per participant within 30 days of enrollment
Phenotype differences in blood biomarkers
Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory, for a comprehensive analysis of targeted hormones and untargeted metabolic systems.
Measured: Samples to be collected once within a 5-day window to control for menstrual cycle, within 30 days of enrollment
Phenotype differences in DNA
Understand phenotypical differences from biological samples comparing women with and without PCOS. Saliva samples are to be collected and analyzed by a commercial laboratory for DNA and metabolomics.
Measured: Samples to be collected once per participant within 30 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start19 Jun 2021
- Primary completion11 Jan 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onegevity Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- Chris D'Adamo, PhD, Principal investigator, University of MarylandChris Mason, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981275
- Sponsor's protocol ID
- HP-00089723
- Status last verified
- Oct 2023
- First submitted
- 7 Jul 2021
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype
- ClinicalTrials.gov ID
- NCT04981275
- Acronym / sponsor ID
- HP-00089723
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Onegevity HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore
- Study start
- 19 Jun 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 28 Jul 2021 (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.
The purpose of this research study is to explore the relationship between the gut microbiome and hormone levels in women diagnosed with PCOS and determine whether there are differences in the gut microbiome between women with PCOS and women without PCOS.
Consented, enrolled participants will complete a health questionnaire, complete a fasted blood draw at a local laboratory, and provide a stool, saliva, and vaginal swab sample for comprehensive biomarkers, hormones, metagenomics, and metabolomics analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with PCOS | – | Other: No intervention studyWomen previously diagnosed with PCOS not using hormonal therapy and without other significant health or endocrine issues |
| Healthy controls | – | Other: No intervention studyWomen self-identifying as generally healthy, not using hormonal therapy, and without any significant health or endocrine issues |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women, ages 18-40, living in the USA (except for NY, NJ, RI, MD, SD, ND, or HI), who have not been using hormonal therapy for at least 3 months and without other significant health issues or medications affecting hormones. Women must be previously diagnosed with PCOS or considered Healthy and not currently pregnant or nursing. Women will be referred to the study by their Physician or word of mouth.
Key inclusion criteria (4 listed)
- Women diagnosed with PCOS or Women who are considered Healthy
- 18-40 years old
- Residing in the USA, except for exclusion states
- Have not been using hormonal therapy for at least 3 months
Key exclusion criteria (4 listed)
- Women using hormonal therapy within the last 3 months
- Diagnosed with other significant health conditions or using medications that will affect hormone levels
- Residing in NY, NJ, MD, RI, ND, SD, or HI
- Pregnant or nursing
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 |
|---|---|---|
| No intervention studyThis observational study will only collect data, not provide any intervention to participants. | Other | Healthy controls, Women with PCOS |
Primary outcome
Phenotype differences in vaginal microbiome
Time frame: Samples to be collected on any day once per participant within 30 days of enrollment
Understand phenotypical differences from biological samples comparing women with and without PCOS. Vaginal swabs are to be collected by women and analyzed with metagenomics and metabolomics sequencing.
Phenotype differences in gut microbiome
Time frame: Samples to be collected once on any day per participant within 30 days of enrollment
Understand phenotypical differences from biological samples comparing women with and without PCOS. Stool samples are to be collected by women and analyzed with metagenomics sequencing.
Phenotype differences in blood biomarkers
Time frame: Samples to be collected once within a 5-day window to control for menstrual cycle, within 30 days of enrollment
Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory, for a comprehensive analysis of targeted hormones and untargeted metabolic systems.
Phenotype differences in DNA
Time frame: Samples to be collected once per participant within 30 days of enrollment
Understand phenotypical differences from biological samples comparing women with and without PCOS. Saliva samples are to be collected and analyzed by a commercial laboratory for DNA and metabolomics.
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 1 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Polycystic Ovary Syndrome
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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.
Chris D'Adamo, PhD principal investigator
University of Maryland
Chris Mason, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Onegevity Health 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 4 inclusion and 4 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 1 Nov 2023. 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?
Phenotype differences in vaginal microbiome (time frame: Samples to be collected on any day once per participant within 30 days of enrollment). The study lists 4 primary outcomes in all. 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 1 Nov 2023.