Gut- and Vaginal Microbiome Composition in Association With PCOS (GuVaPCOS)

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: Venous blood sample, vaginal swab

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Xu Shan Gao, drs.; Phone Number: +31631016348; Email: x.gao@erasmusmc.nl
• Study Contact Backup: Name: Sam Schoenmakers, Dr. drs.; Email: s.schoenmakers@erasmusmc.nl

Study Locations

• Netherlands
  • South-Holland
    • Rotterdam, South-Holland, Netherlands, 3015GD
      • Recruiting
      • Erasmus University Medical Center
      • Contact: Xu Shan Gao, Drs; Phone Number: +31631016348; Email: x.gao@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients at the outpatient clinic of Reproductive Medicine.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Polycystic ovary syndrome (PCOS); Hormonal screening; Vaginal swab; Fecal sample; Blood samples; Food Frequency Questionnaire	Other: 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	Other: Venous blood sample, vaginal swab; Venous blood samples and vaginal swab will be obtained on the same day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Sam Schoenmakers, Dr. drs., Division of Obstetrics and Fetal Medicine, Department of Obstetrics and Gynecology; Study Director: Joop S.E. Laven, Prof. dr., Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: polycystic ovary syndrome; gut microbiome; vaginal microbiome
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome
• Other Study ID Numbers: NL80648.078.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No