Polycystic Ovary SyndromeGuVaPCOSNCT05706922
Gut- and Vaginal Microbiome Composition in Association With PCOS
An observational study of Polycystic Ovary Syndrome, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Venous blood sample, vaginal swab
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Nov 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients at the outpatient clinic of Reproductive Medicine.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sam Schoenmakers, Dr. drs. contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam, South Holland, 3015GD
Xu Shan Gao, Drs, +31631016348, x.gao@erasmusmc.nl
About this study
Official title: Changes in the Gut- and Vaginal Microbiome Composition in Association With PCOS Clinical Phenotypes.
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
- Being tested
- Venous blood sample, vaginal swab
- Keywords
- gut microbiome, vaginal microbiome, polycystic ovary syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood sample, vaginal swabOther
Venous blood samples and vaginal swab will be obtained on the same day.
| Study group | Role | What they receive |
|---|---|---|
| Polycystic ovary syndrome (PCOS) | * Hormonal screening
* Vaginal swab
* Fecal sample
* Blood samples
* Food Frequency Questionnaire Receives: Other: Venous blood sample, vaginal swab | |
| Control group | * Hormonal screening
* Vaginal swab
* Fecal sample
* Blood samples
* Food Frequency Questionnaire Receives: Other: Venous blood sample, vaginal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial composition of the gut in women with PCOS and control group
Bacterial composition in the gut is analysed using 16S rRNA gene sequencing
Measured: 1 week
Secondary outcomes (4)
Bacterial composition of the vagina in women with PCOS and control group
Bacterial composition in the vagina is analysed using 16S rRNA gene sequencing
Measured: 1 week
Difference in bacterial composition of the vagina and gut in women with PCOS
Relative abundance of bacterial communities
Measured: 1 week
Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS)
Relative abundance of bacterial communities
Measured: 1 week
To analyse potential metabolic profiles characterizing different phenotypes of PCOS
Expression of metabolic indicators (metabolomics)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start16 Nov 2023
- Primary completion31 Jul 2024
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Schoenmakers, Erasmus Medical Center
- Investigators
- Sam Schoenmakers, Dr. drs., Principal investigator, Division of Obstetrics and Fetal Medicine, Department of Obstetrics and GynecologyJoop S.E. Laven, Prof. dr., Study director, Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706922
- Sponsor's protocol ID
- NL80648.078.22
- Acronym
- GuVaPCOS
- Status last verified
- Sep 2024
- First submitted
- 11 Jan 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Gut- and Vaginal Microbiome Composition in Association With PCOS Clinical Phenotypes.
- ClinicalTrials.gov ID
- NCT05706922
- Acronym / sponsor ID
- GuVaPCOS / NL80648.078.22
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- gut microbiome, vaginal microbiome, polycystic ovary syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polycystic ovary syndrome (PCOS) | – | Other: Venous blood sample, vaginal swab* Hormonal screening * Vaginal swab * Fecal sample * Blood samples * Food Frequency Questionnaire |
| Control group | – | Other: Venous blood sample, vaginal swab* Hormonal screening * Vaginal swab * Fecal sample * Blood samples * Food Frequency Questionnaire |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients at the outpatient clinic of Reproductive Medicine.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- BMI <18
- Smoking
- Diabetes Mellitus or use of insulin sensitizer
- Chronic and acute infection diseases
- Endometriosis (American Fertility Score (AFS) III/IV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood sample, vaginal swabVenous blood samples and vaginal swab will be obtained on the same day. | Other | Control group, Polycystic ovary syndrome (PCOS) |
Primary outcome
Bacterial composition of the gut in women with PCOS and control group
Time frame: 1 week
Bacterial composition in the gut is analysed using 16S rRNA gene sequencing
4 secondary outcomes
Bacterial composition of the vagina in women with PCOS and control group
Time frame: 1 week
Difference in bacterial composition of the vagina and gut in women with PCOS
Time frame: 1 week
Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS)
Time frame: 1 week
To analyse potential metabolic profiles characterizing different phenotypes of PCOS
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Schoenmakers, Dr. drs. contact
Sam Schoenmakers, Dr. drs. principal investigator
Division of Obstetrics and Fetal Medicine, Department of Obstetrics and Gynecology
Joop S.E. Laven, Prof. dr. study director
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Shan Gao, drs. (+31631016348, x.gao@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial composition of the gut in women with PCOS and control group (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.