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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polycystic ovary syndrome (PCOS) |
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| |
| Control group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous blood sample, vaginal swab | Other | Venous blood samples and vaginal swab will be obtained on the same day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial composition of the gut in women with PCOS and control group | Bacterial composition in the gut is analysed using 16S rRNA gene sequencing | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial composition of the vagina in women with PCOS and control group | Bacterial composition in the vagina is analysed using 16S rRNA gene sequencing | 1 week |
| Difference in bacterial composition of the vagina and gut in women with PCOS |
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Inclusion criteria
Exclusion criteria
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Patients at the outpatient clinic of Reproductive Medicine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Shan Gao, drs. | Contact | +31631016348 | x.gao@erasmusmc.nl | |
| Sam Schoenmakers, Dr. drs. | Contact | s.schoenmakers@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Sam Schoenmakers, Dr. drs. | Division of Obstetrics and Fetal Medicine, Department of Obstetrics and Gynecology | Principal Investigator |
| Joop S.E. Laven, Prof. dr. | Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Center | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2022 | Jan 23, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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Relative abundance of bacterial communities
| 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 | 1 week |
| To analyse potential metabolic profiles characterizing different phenotypes of PCOS | Expression of metabolic indicators (metabolomics) | 1 week |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |