Gut- and Vaginal Microbiome Composition in Association With PCOS

Trial Title: Gut- and Vaginal Microbiome Composition in Association With PCOS

NCT ID: NCT05706922

Condition: Polycystic Ovary Syndrome

Conditions: Official terms:
Polycystic Ovary Syndrome

Conditions: Keywords:
gut microbiome
vaginal microbiome
polycystic ovary syndrome

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Venous blood sample, vaginal swab
Description: Venous blood samples and vaginal swab will be obtained on the same day.
Arm group label: Control group
Arm group label: Polycystic ovary syndrome (PCOS)

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.

Criteria for eligibility:

Study pop:
Patients at the outpatient clinic of Reproductive Medicine.

Sampling method: Probability Sample
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

Gender: Female

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Erasmus University Medical Center

Address:
City: Rotterdam
Zip: 3015GD
Country: Netherlands

Status: Recruiting

Contact:
Last name: Xu Shan Gao, Drs

Phone: +31631016348
Email: x.gao@erasmusmc.nl

Start date: November 16, 2023

Completion date: December 2024

Lead sponsor:
Agency: Erasmus Medical Center
Agency class: Other

Source: Erasmus Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05706922