Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure

Study Overview
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Brief Summary
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Research objective. - To study the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with non-communicable diseases and adverse outcomes in women with premature ovarian failure. Research objectives: To study the associations between combinations of single-nucleotide polymorphisms and behavioural risk factors with heart rate disorders and adverse outcomes in women with premature ovarian failure Examine the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with stable STIs in women with premature ovarian failure. Examine the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with thrombomolia in women with premature ovarian failure Study the associations between combinations of single nucleotide polymorphisms and behavioural risk factors and adverse cardiovascular outcomes in women with premature ovarian failure.

Detailed Description
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Methods of research: Questionnaire . Clinical examination Blood levels of sex hormones Blood lipid spectrum Coagulogram Glycemic profile EchoCG SMAD ECG Daily ECG monitoring Questionnaire EQ-5D Single-nucleotide polymorphisms of genes of the reninangyotensin-aldosterone system group (AGT, ACE), endothelial dysfunction (NOS3, EDN1), thrombosis-associated (ITGB3, ITGA2, FGB, GPIBA, SERPINE PAI1), pro-inflammatory (CRP, IL17A, IL2, IL10 1, IL10 2, TNFα, CRP 4, IL6, TLR2, TLR3, TLR4, TLR6, TLR9) polymorphisms. Subject of study. Women under 45 with Premature Ovarian Failure (PED). It is planned to include 615 people in the study. The study will have both prospective and retrospective parts. Patients will be divided into 4 groups: Women with OED without cardiovascular disease Women with OAI who have cardiovascular disease Control group No 1 Women with normal ovarian function without cardiovascular disease. Control group 2 Women with normal ovarian function without cardiovascular disease. The groups will be comparable in number. All data obtained will be calculated for each group separately. A comparative analysis will then be made for all four groups. Traditional risk factors, existing non-communicable diseases and the quality of life of patients will be identified using standard research methods. The selected polymorphism groups are associated with various pathological processes leading to unfavourable cardiovascular outcomes. Their role has not been assessed in patients with premature ovarian failure. The power of the study was calculated based on the expected number of adverse outcomes. The division of patients into groups is related to the need to compare and evaluate unfavourable outcomes and non-communicable diseases in patients in order to create a risk scale.

Official Title
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Associations of Combinations of Single-nucleotide Polymorphisms and Behavioural Risk Factors With Non-communicable Diseases and Adverse Outcomes in Women With Premature Ovarian Failure

Conditions
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Primary Ovarian Insufficiency, Cardiovascular Diseases, Menopause, Premature, Coronary Disease, Pulmonary Embolism, Arrhythmias, Cardiac, Polymorphism, Single Nucleotide

Intervention / Treatment
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* Behavioral: Taking a person's venous blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women under 45 years old presence of premature ovarian insufficiency in the medical history Exclusion Criteria: male gender age over 45 years

Ages Eligible for Study
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Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Women diagnosed with premature ovarian failure were selected from different medical institutions in Ryazan and the Ryazan region, all information was communicated to them in a clear and understandable way and they also signed an informed voluntary consent. Premature ovarian failure - defined as the occurrence of secondary amenorrhoea ≥4 months at the age of under 45 years together with FSH levels above 40 IU/L. Inclusion criteria were: female gender, age at menopause < 45 years, onset of secondary amenorrhoea ≥ 4 months, FSH levels higher than 40 IU/l, or a previous diagnosis of premature ovarian failure. The control group was formed based on comparability criteria of gender, age and BMI to minimise the influence of phenotype on the results. The control group consisted of women without signs of PEN, so we aimed to compare the health status of these two different groups of women.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study of single-nucleotide polymorphisms in women diagnosed with premature ovarian failure<br>Study of genes affecting single nucleotide polymorphisms: Reninangiotensin-aldosterone system (AGT, ACE), endothelial dysfunction (NOS3, EDN1), thrombosis-associated (ITGB3, ITGA2, FGB, GPIBA, SERPINE PAI1), proinflammatory (CRP, IL17A, IL2, IL10 1, IL10 2, TNFα, CRP 4, IL6, TLR2, TLR3, TLR4, TLR6, TLR9) in the study group of women diagnosed with premature ovarian failure. | Behavioral: Taking a person's venous blood<br>* Collection of 5 ml of the patient's venous blood, carried out according to standard rules.<br>|
| Active Comparator: Study of single-nucleotide polymorphisms in a control group of healthy women<br>Study of genes affecting single nucleotide polymorphisms: Reninangiotensin-aldosterone system (AGT, ACE), endothelial dysfunction (NOS3, EDN1), thrombosis-associated (ITGB3, ITGA2, FGB, GPIBA, SERPINE PAI1), pro-inflammatory (CRP, IL17A, IL2, IL10 1, IL10 2, TNFα, CRP 4, IL6, TLR2, TLR3, TLR4, TLR6, TLR9) in a control group of healthy women . | Behavioral: Taking a person's venous blood<br>* Collection of 5 ml of the patient's venous blood, carried out according to standard rules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age (years) | Patient age in years | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menarche (years) | Age of onset of menarche expressed in years | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary heart disease, pulmonary embolism, cardiac arrhythmias, heart rhythm disturbances, single nucleotide polymorphisms, premature ovarian failure, hypoestrogenism, artificial menopause, cardiovascular disease, chronic non-infectious disease, cardiovascular outcomes