An observational study in Polycystic Ovary Syndrome, sponsored by Onegevity Health. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Onegevity Health · Observational
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 81 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Onegevity Health is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Women previously diagnosed with PCOS not using hormonal therapy and without other significant health or endocrine issues
Other: No intervention study
Women self-identifying as generally healthy, not using hormonal therapy, and without any significant health or endocrine issues
Other: No intervention study
This observational study will only collect data, not provide any intervention to participants.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Samples to be collected once per participant within 30 days of enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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