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

Ryazan State Medical University

Status: Completed

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

Treatments: Behavioral: Taking a person's venous blood

Study type: Interventional

Funder types: Other

Identifiers

NCT04943354

20-315-90017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 patients

Sex: Female

Ages: Under 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• women under 45 years old
• presence of premature ovarian insufficiency in the medical history

Exclusion criteria

• male gender
• age over 45 years

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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238 participants in 2 patient groups

Study of single-nucleotide polymorphisms in women diagnosed with premature ovarian failure

Active Comparator group

Description:

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.

Treatment:

Behavioral: Taking a person's venous blood

Study of single-nucleotide polymorphisms in a control group of healthy women

Active Comparator group

Description:

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 .

Treatment:

Behavioral: Taking a person's venous blood