Clinical trial NCT05706922: Gut- and Vaginal Microbiome Composition in Association With PCOS
Official title: Changes in the Gut- and Vaginal Microbiome Composition in Association With PCOS Clinical Phenotypes.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovary Syndrome
Keywords: gut microbiome
vaginal microbiome
polycystic ovary syndrome
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at the outpatient clinic of Reproductive Medicine.

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

Primary outcomes:
measure: Bacterial composition of the gut in women with PCOS and control group
timeFrame: 1 week
Secondary outcomes:
measure: Bacterial composition of the vagina in women with PCOS and control group
timeFrame: 1 week
measure: Difference in bacterial composition of the vagina and gut in women with PCOS
timeFrame: 1 week
measure: Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS)
timeFrame: 1 week
measure: To analyse potential metabolic profiles characterizing different phenotypes of PCOS
timeFrame: 1 week
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: South-Holland
Study officials:
affiliation: Division of Obstetrics and Fetal Medicine, Department of Obstetrics and Gynecology
name: Sam Schoenmakers, Dr. drs.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology
name: Joop S.E. Laven, Prof. dr.
role: STUDY_DIRECTOR
References: