Gut- and Vaginal Microbiome Composition in Association With PCOS

NCT05706922 | Recruiting

• 1 other identifier: NL80648.078.22
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

gut microbiome; vaginal microbiome; polycystic ovary syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Bacterial composition of the vagina in women with PCOS and control group

  1 week

• Difference in bacterial composition of the vagina and gut in women with PCOS

  1 week

• Difference in bacterial composition of the vagina and gut between overweight/obese and lean patients (with/without PCOS)

  1 week

• To analyse potential metabolic profiles characterizing different phenotypes of PCOS

  1 week

Study Arms (2)

Polycystic ovary syndrome (PCOS)

* Hormonal screening * Vaginal swab * Fecal sample * Blood samples * Food Frequency Questionnaire

Other: Venous blood sample, vaginal swab

Control group

* Hormonal screening * Vaginal swab * Fecal sample * Blood samples * Food Frequency Questionnaire

Other: Venous blood sample, vaginal swab

Interventions

Venous blood sample, vaginal swab OTHER

Venous blood samples and vaginal swab will be obtained on the same day.

Control group; Polycystic ovary syndrome (PCOS)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients at the outpatient clinic of Reproductive Medicine.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

Xu Shan Gao, drs.

CONTACT

+31631016348; x.gao@erasmusmc.nl

Sam Schoenmakers, Dr. drs.

CONTACT

s.schoenmakers@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 31, 2023
• Study Start: November 16, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

NL (1)