NCT05706922 Gut- and Vaginal Microbiome Composition in Association With PCOS
| NCT ID | NCT05706922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Polycystic Ovary Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-11-16 |
| Primary Completion | 2024-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-11-16 with a primary completion date of 2024-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Sam Schoenmakers, Dr. drs.
PRINCIPAL INVESTIGATOR
Division of Obstetrics and Fetal Medicine, Department of Obstetrics and Gynecology
Frequently Asked Questions
Who can join the NCT05706922 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Polycystic Ovary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05706922 currently recruiting?
Yes, NCT05706922 is actively recruiting participants. Contact the research team at x.gao@erasmusmc.nl for enrollment information.
Where is the NCT05706922 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT05706922 clinical trial?
NCT05706922 is sponsored by Erasmus Medical Center. The principal investigator is Sam Schoenmakers, Dr. drs. at Division of Obstetrics and Fetal Medicine, Department of Obstetrics and Gynecology. The trial plans to enroll 200 participants.