An observational study in Polycystic Ovary Syndrome, sponsored by Erasmus Medical Center. Recruiting at 1 site in Netherlands. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Erasmus Medical Center · Observational
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects up to 10% of the reproductive-aged women worldwide. The etiology is still unknown and treatment therefore remains symptomatic. Studies indicate a possible role of the gut microbiome in the pathology of PCOS. PCOS women have a disturbed gut microbiome, with certain species associated with the PCOS characteristics:hyperandrogenism, ovarian dysfunction, obesity, glucose intolerance and insulin resistance. Although differences have been found in gut microbiome composition between PCOS and healthy women, the literature is inconclusive regarding the difference in gut microbiome biodiversity. Studies examining the vaginal microbiome in PCOS women show consistent results with specific species in the vaginal microbiome. However, there are only few studies on the vaginal microbiome in PCOS women and no studies have yet investigated the correlation between sex-specific hormones and PCOS characteristics. More research is needed to understand the function of the microbiome in the pathophysiology of PCOS, so that this can offer perspectives in future therapies.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's planned enrollment of 200 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients at the outpatient clinic of Reproductive Medicine.
Exclusion criteria
* Hormonal screening * Vaginal swab * Fecal sample * Blood samples * Food Frequency Questionnaire
Other: Venous blood sample, vaginal swab
* Hormonal screening * Vaginal swab * Fecal sample * Blood samples * Food Frequency Questionnaire
Other: Venous blood sample, vaginal swab
Venous blood samples and vaginal swab will be obtained on the same day.
Bacterial composition of the gut in women with PCOS and control group
Bacterial composition in the gut is analysed using 16S rRNA gene sequencing
Time frame: 1 week
Bacterial composition of the vagina in women with PCOS and control group
Bacterial composition in the vagina is analysed using 16S rRNA gene sequencing
Time frame: 1 week
Difference in bacterial composition of the vagina and gut in women with PCOS
Relative abundance of bacterial communities
Time frame: 1 week
Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS)
Relative abundance of bacterial communities
Time frame: 1 week
To analyse potential metabolic profiles characterizing different phenotypes of PCOS
Expression of metabolic indicators (metabolomics)
Time frame: 1 week
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
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