Actively Recruiting

Age: 20Years - 45Years
FEMALE
Healthy Volunteers
ID06167135

Polycystic Ovary Syndrome, Insulin Resistance, Infertility, Obesity, and Associated Mitochondrial Dysfunction in Hungarian Patients

Led by Semmelweis University · Updated on 2023-12-18

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand the role of mitochondrial dysfunction in women diagnosed with polycystic ovary syndrome (PCOS), insulin resistance, infertility, and related conditions. PCOS is a complex disorder affecting women of reproductive age, characterized by endocrine problems such as ovulatory dysfunction, obesity, insulin resistance, and specific ovarian changes. The study explores how mitochondrial issues may contribute to these conditions and their impact on fertility and metabolism. The study plans to enroll 150 female patients of fertile age with PCOS, insulin resistance, infertility, or mitochondrial disease, along with the same number of age- and sex-matched healthy controls. Researchers will examine biomarkers linked to mitochondrial dysfunction, including mitochondrial DNA abnormalities. The focus is on mitochondrial dynamics, bioenergetics, and autophagy pathways to better understand their role in PCOS and insulin resistance. Participants will be observed over one year, with researchers measuring serum glucose and insulin levels as primary outcomes, along with clinical pregnancy rates. Secondary outcomes include hormone level assessments such as female sex hormones and thyroid hormones. The study involves collecting clinical data and biomarker information to improve understanding and potentially identify new biomarkers or treatment targets. The total duration and participation involve regular assessments over the study period.

CONDITIONS

Brief Title

Polycystic Ovary Syndrome, Mitochondrial Dysfunction, Obesity, Insulin Resistance Infertility (POMODORI) Cohort

Who Can Participate

Age: 20Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of polycystic ovary syndrome (PCOS) or insulin resistance (IR) linked with multisystemic phenotypes and mitochondrial dysfunction
  • History of infertility associated with multisystemic phenotypes and mitochondrial dysfunction
  • Known history of mitochondrial dysfunction combined with PCOS and/or IR
  • Good general health without serious medical conditions that would make participation risky
Not Eligible

You will not qualify if you...

  • Poor cooperation
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 year

Participants undergo assessments to evaluate mitochondrial function, insulin resistance, and polycystic ovary syndrome characteristics.

Periodic visits over the course of 1 year

Long-term Monitoring

Duration - Up to 1 year

Participants are observed for serum glucose and insulin levels, hormone levels, and clinical pregnancy outcomes related to PCOS and mitochondrial dysfunction.

Periodic visits over the course of 1 year

Trial Site Locations

Total: 1 location

1

Semmelweis University

Budapest, Hungary, 1082

Actively Recruiting

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Research Team

V

Vera Várhegyi, MD

A

Anikó Gál, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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