Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Poor cooperation
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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