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Gut- and Vaginal Microbiome Composition in Association With PCOS

NCT05706922 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

OTHER

Venous blood sample, vaginal swab

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

Sponsors & Collaborators

Principal Investigators

  • Sam Schoenmakers, Dr. drs. · Division of Obstetrics and Fetal Medicine, Department of Obstetrics and Gynecology

  • Joop S.E. Laven, Prof. dr. · Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2024-07-31
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05706922 on ClinicalTrials.gov