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

NCT06167135 | Recruiting

• 1 other identifier: 15672-6/2022/EÜIG
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility, Female; Polycystic Ovary Syndrome; Insulin Resistance; Primary Ovarian Insufficiency; Mitochondrial Alteration; Obesity

Keywords

Polycystic Ovary Syndrome; Insulin Resistance; Female Infertility; Obesity; Mitochondrial Dysfunction; Mitochondrial Alteration; Primary Ovarian Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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

  One year

• Clinical Pregnancy Rate

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

  One year

Secondary Outcomes (1)

• Baseline Female Sex Hormone Levels and Thyroid Hormone Levels

  One year

Other Outcomes (3)

• Body Mass Index (BMI)

  One year

• Metformin dose

  One year

• GLP-1 receptor agonist dose

  One year

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• poor cooperation
• refusal to participate in the study

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, 1082, Hungary

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA isolated from blood sample and urine sample (urine epithelial cells)

MeSH Terms

Conditions

Infertility, Female; Polycystic Ovary Syndrome; Insulin Resistance; Primary Ovarian Insufficiency; Obesity; Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vera Várhegyi, MD

CONTACT

+36206663493; varhegyi.vera@semmelweis.hu

Anikó Gál, PhD

CONTACT

+36206632516; gal.aniko@med.semmelweis-univ.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University professor

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 12, 2023
• Study Start: September 10, 2021
• Primary Completion (Estimated): September 30, 2033
• Study Completion (Estimated): September 30, 2033
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)