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

Cardiovascular Diseases Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04943354
• Study type: Interventional
• Source: Ryazan State Medical University
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Completion date: December 12, 2023