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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-45
SponsorSemmelweis University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
One year
2

Clinical Pregnancy Rate

Clinical pregnancy rate = the number of clinical pregnancies/the total number of participants in the patient cohort × 100%

Time frame
One year

Secondary outcomes

1

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

Time frame
One year

Other outcomes

1

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).

Time frame
One year
2

Metformin dose

Daily dose of metformin used (expressed in milligrams)

Time frame
One year
3

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)

Time frame
One year

Sponsors and contacts

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