Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT06167135
Status:
RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polycystic Ovary Syndrome, Mitochondrial Dysfunction, Obesity, Insulin Resistance Infertility (POMODORI) Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D028361', 'term': 'Mitochondrial Diseases'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA isolated from blood sample and urine sample (urine epithelial cells)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '12 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2033-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2023-12-03', 'studyFirstSubmitQcDate': '2023-12-03', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': 'One year', 'description': '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).'}, {'measure': 'Metformin dose', 'timeFrame': 'One year', 'description': 'Daily dose of metformin used (expressed in milligrams)'}, {'measure': 'GLP-1 receptor agonist dose', 'timeFrame': 'One year', 'description': '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)'}], 'primaryOutcomes': [{'measure': 'Serum Glucose and Insulin Levels', 'timeFrame': 'One year', 'description': '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'}, {'measure': 'Clinical Pregnancy Rate', 'timeFrame': 'One year', 'description': 'Clinical pregnancy rate = the number of clinical pregnancies/the total number of participants in the patient cohort × 100%'}], 'secondaryOutcomes': [{'measure': 'Baseline Female Sex Hormone Levels and Thyroid Hormone Levels', 'timeFrame': 'One year', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polycystic Ovary Syndrome', 'Insulin Resistance', 'Female Infertility', 'Obesity', 'Mitochondrial Dysfunction', 'Mitochondrial Alteration', 'Primary Ovarian Insufficiency'], 'conditions': ['Infertility, Female', 'Polycystic Ovary Syndrome', 'Insulin Resistance', 'Primary Ovarian Insufficiency', 'Mitochondrial Alteration', 'Obesity']}, 'descriptionModule': {'briefSummary': '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.\n\nDuring the research biomarkers already with mitochondrial dysfunction in the scientific literature and common mtDNA abnormalities (deletions, point mutations, copy number changes, etc.) are examined.', 'detailedDescription': 'Mitochondrial dysfunction can be involved in the development of clinically heterogeneous diseases affecting multiple tissues and organs and can manifest at any age. Clinical signs are mainly manifested in the most energy-demanding tissues, such as the central nervous system, striated muscles, cardiac musculature, endocrine glands, liver, kidney, and sensory organs.\n\nPolycystic ovarian syndrome (PCOS) is a multifactorial disorder with endocrine dysfunction characterized by ovulatory dysfunction, obesity, insulin resistance (IR), hirsutism, mild persistent inflammation, and ultrasonographically confirmed polycystic ovarian morphology. PCOS affects 5-15% of women of reproductive age. PCOS and IR are also common and treatable causes of infertility. As a result of delaying childbearing until later in life, this problem is affecting more and more couples. In the present study, the investigators hypothesize that PCOS, IR, and infertility associated with these conditions may also be a manifestation of mitochondrial dysfunction, the role of mitochondrial dysfunction in these conditions has been investigated to a limited extent based on the current literature.\n\nRecent literature has shown that mitochondrial dynamics and morphology are two of the major factors in the development of insulin resistance and diabetes mellitus by regulating glucose metabolism. The investigators of this study cohort hypothesize that PCOS and IR may also be a manifestation of a primary mitochondrial pathology, the prevalence of IR and PCOS in primary mitochondrial patients has not yet been investigated based on the current literature. Recent literature suggests that mitochondrial dynamics and morphology are two of the main factors in the development of insulin resistance and diabetes mellitus by regulating glucose metabolism.\n\nIn the present experimental design, mitochondrial dynamics, bioenergetics, and autophagy pathways are hypothesized to play a key role in the pathomechanisms of PCOS and IR. A better understanding of the role of mitochondrial pathways in the pathophysiology of PCOS and IR may help to develop new biomarkers or therapeutic targets.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of polycystic ovary syndrome (PCOS) or insulin resistance (IR) associated with other multisystemic phenotypes, mitochondrial dysfunction\n* history of infertility associated with other multisystemic phenotypes, mitochondrial dysfunction\n* a known history of mitochondrial dysfunction and PCOS and/or IR\n* general health is good and there is no serious general medical condition that would prevent participation would make participation highly risky\n\nExclusion Criteria:\n\n* poor cooperation\n* refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT06167135', 'acronym': 'POMODORI', 'briefTitle': 'Polycystic Ovary Syndrome, Mitochondrial Dysfunction, Obesity, Insulin Resistance Infertility (POMODORI) Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'Polycystic Ovary Syndrome, Insulin Resistance, Infertility, Obesity, and the Associated Mitochondrial Dysfunction With These Disorders in Hungarian Patients', 'orgStudyIdInfo': {'id': '15672-6/2022/EÜIG'}}, 'contactsLocationsModule': {'locations': [{'zip': '1082', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Vera Várhegyi, MD', 'role': 'CONTACT', 'email': 'varhegyi.vera@semmelweis.hu', 'phone': '+36206663493'}, {'name': 'Anikó Gál, PhD', 'role': 'CONTACT', 'email': 'gal.aniko@med.semmelweis-univ.hu', 'phone': '+36206632516'}], 'facility': 'Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'centralContacts': [{'name': 'Vera Várhegyi, MD', 'role': 'CONTACT', 'email': 'varhegyi.vera@semmelweis.hu', 'phone': '+36206663493'}, {'name': 'Anikó Gál, PhD', 'role': 'CONTACT', 'email': 'gal.aniko@med.semmelweis-univ.hu', 'phone': '+36206632516'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University professor', 'investigatorFullName': 'Prof. Dr. Várbíró Szabolcs', 'investigatorAffiliation': 'Semmelweis University'}}}}