Gut- and Vaginal Microbiome Composition in Association With PCOS
NCT ID: NCT05706922
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-11-16
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Polycystic ovary syndrome (PCOS)
* Hormonal screening
* Vaginal swab
* Fecal sample
* Blood samples
* Food Frequency Questionnaire
Venous blood sample, vaginal swab
Venous blood samples and vaginal swab will be obtained on the same day.
Control group
* Hormonal screening
* Vaginal swab
* Fecal sample
* Blood samples
* Food Frequency Questionnaire
Venous blood sample, vaginal swab
Venous blood samples and vaginal swab will be obtained on the same day.
Interventions
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Venous blood sample, vaginal swab
Venous blood samples and vaginal swab will be obtained on the same day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Sam Schoenmakers
Principal Investigator
Principal Investigators
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Sam Schoenmakers, Dr. drs.
Role: PRINCIPAL_INVESTIGATOR
Division of Obstetrics and Fetal Medicine, Department of Obstetrics and Gynecology
Joop S.E. Laven, Prof. dr.
Role: STUDY_DIRECTOR
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology
Locations
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Erasmus University Medical Center
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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NL80648.078.22
Identifier Type: -
Identifier Source: org_study_id
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