Gut- and Vaginal Microbiome Composition in Association With PCOS (GuVaPCOS)

Erasmus University

Status

Enrolling

Conditions

Polycystic Ovary Syndrome

Treatments

Other: Venous blood sample, vaginal swab

Study type

Observational

Funder types

Other

Identifiers

NCT05706922

NL80648.078.22

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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