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

Not Applicable

Completed

• Conditions: Menopause, Premature; Polymorphism, Single Nucleotide; Pulmonary Embolism; Arrhythmias, Cardiac; Primary Ovarian Insufficiency; Cardiovascular Diseases; Coronary Disease
• Interventions: Behavioral: Taking a person's venous blood

• Registration Number: NCT04943354
• Lead Sponsor: Ryazan State Medical University

Brief 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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-06-29
• Primary Completion: 2022-06-03
• Status Verified: 2022-07
• Study Completion: 2023-12-12
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 238

Inclusion Criteria

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

Exclusion Criteria

• male gender
• age over 45 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study of single-nucleotide polymorphisms in a control group of healthy women	Taking a person's venous blood	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 .
Study of single-nucleotide polymorphisms in women diagnosed with premature ovarian failure	Taking a person's venous blood	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.

Primary Outcome Measures

Name	Time	Method
Age (years)	2 year	Patient age in years

Secondary Outcome Measures

Name	Time	Method
Menarche (years)	2 year	Age of onset of menarche expressed in years

Trial Locations

Locations (1)

Sergey Vladimirovich Lopukhov; 🇷🇺 Ryazan, Ryazan Region, Russian Federation