About this trial
Enrolling of 150 female patients of fertile age diagnosed with PCOS, insulin resistance, infertility, or mitochondrial disease, and the same number of age- and sex-matched controls are planned.
During the research biomarkers already with mitochondrial dysfunction in the scientific literature and common mtDNA abnormalities (deletions, point mutations, copy number changes, etc.) are examined.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Presence of polycystic ovary syndrome (PCOS) or insulin resistance (IR) associated with other multisystemic phenotypes, mitochondrial dysfunction
history of infertility associated with other multisystemic phenotypes, mitochondrial dysfunction
a known history of mitochondrial dysfunction and PCOS and/or IR
general health is good and there is no serious general medical condition that would prevent participation would make participation highly risky
Disqualifiers
poor cooperation
refusal to participate in the study
Trial population
Female patients of fertile age (between 20-45 years) who are being treated for insulin resistance and/or polycystic ovary syndrome, infertility, multi-organ symptoms, or possible primary ovarian insufficiency.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Serum Glucose and Insulin Levels
The serum glucose and insulin levels are calculated by using plasma concentrations of insulin and glucose obtained during 120 min of a standard (75 g glucose) OGTT. Fasting, 1h and 2h glucose and insulin levels are measured
Clinical Pregnancy Rate
Clinical pregnancy rate = the number of clinical pregnancies/the total number of participants in the patient cohort × 100%
Secondary outcomes
Baseline Female Sex Hormone Levels and Thyroid Hormone Levels
Measurement of the baseline female sex hormone: anti-Mullerian hormone (AMH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol, progesterone, total testosterone, free testosterone, SHBG) and thyroid hormone levels (thyroid stimulating hormone (TSH), T3, T4 + anti-thyroid peroxidase antibody, anti-thyroglobulin antibody) - in the unit of measurement used for the hormone concerned
Other outcomes
Body Mass Index (BMI)
The body mass index (BMI) is the metric currently in use for defining anthropometric height/weight characteristics in adults and classifying (categorizing) them into groups (expressed in kg/m2).
Metformin dose
Daily dose of metformin used (expressed in milligrams)
GLP-1 receptor agonist dose
Daily or weekly dose of the used glucagon-like peptide-1 (GLP-1) agonist depending on the exact type of active substance (expressed in milligrams)
Sponsors and contacts
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