Clinical Trials Directory

Trials / Completed

CompletedNCT04943354

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

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
Phase
N/A
Study type
Interventional
Enrollment
238 (actual)
Sponsor
Ryazan State Medical University · Academic / Other
Sex
Female
Age
45 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTaking a person's venous bloodCollection of 5 ml of the patient's venous blood, carried out according to standard rules.

Timeline

Start date
2020-09-01
Primary completion
2022-06-03
Completion
2023-12-12
First posted
2021-06-29
Last updated
2024-03-12

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT04943354. Inclusion in this directory is not an endorsement.