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

NCT ID: NCT06167135

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-10

Study Completion Date

2033-09-30

Brief Summary

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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.

Detailed Description

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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.

Polycystic 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.

Recent 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.

In 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.

Conditions

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

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* poor cooperation
* refusal to participate in the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Várbíró Szabolcs

University professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Semmelweis University

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Vera Várhegyi, MD

Role: CONTACT

Phone: +36206663493

Email: [email protected]

Anikó Gál, PhD

Role: CONTACT

Phone: +36206632516

Email: [email protected]

Facility Contacts

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Vera Várhegyi, MD

Role: primary

Anikó Gál, PhD

Role: backup

Other Identifiers

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15672-6/2022/EÜIG

Identifier Type: -

Identifier Source: org_study_id