RecruitingNCT05706922

Gut- and Vaginal Microbiome Composition in Association With PCOS

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


Sponsor

Erasmus Medical Center

Enrollment

200 participants

Start Date

Nov 16, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria8

  • 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 Criteria8

  • 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

Interventions

OTHERVenous blood sample, vaginal swab

Venous blood samples and vaginal swab will be obtained on the same day.


Locations(1)

Erasmus University Medical Center

Rotterdam, South Holland, Netherlands

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NCT05706922


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