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Recruiting NCT05706922

Gut- and Vaginal Microbiome Composition in Association With PCOS

— Observational Polycystic Ovary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venous blood sample, vaginal swab.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Changes in the Gut- and Vaginal Microbiome Composition in Association With PCOS Clinical Phenotypes.

Overview

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.

Interventions

  • Other Venous blood sample, vaginal swab
    Venous blood samples and vaginal swab will be obtained on the same day.

Primary outcome measures

  • Bacterial composition of the gut in women with PCOS and control group [Time frame: 1 week]
Secondary outcome measures (4)
  • Bacterial composition of the vagina in women with PCOS and control group [Time frame: 1 week]
  • Difference in bacterial composition of the vagina and gut in women with PCOS [Time frame: 1 week]
  • Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS) [Time frame: 1 week]
  • To analyse potential metabolic profiles characterizing different phenotypes of PCOS [Time frame: 1 week]

Eligibility criteria

Inclusion criteria

  • Caucasian
  • Willing to provide vaginal swab and stool sample
  • Willing to provide informed consent
  • Sufficient command of the Dutch language
  • Diagnosed with PCOS at Erasmus MC using the Rotterdam criteria by the presence of at least two of the following criteria
  • Clinical or biochemical hyperandrogenism (modified Ferriman-Gallway score >5; testosterone level >2nmol/L, Free Androgen Index > 2.9)
  • Oligomenorrorrhea or amenorrhea
  • Polycystic ovaries.

Exclusion criteria

  • BMI <18
  • Smoking
  • Diabetes Mellitus or use of insulin sensitizer
  • Chronic and acute infection diseases
  • Endometriosis (American Fertility Score (AFS) III/IV)
  • Elevated prolactin levels, thyroid disease, Cushing disease or gastro-intestinal disease
  • The use of hormonal contraceptives, and other steroid hormones in the last 3 months
  • Use of antibiotics, probiotics or laxatives in the last 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Netherlands · 1 center
  • Erasmus University Medical Center — Rotterdam

Identifiers

NCT: NCT05706922 · NL80648.078.22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗