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

Last updated: March 11, 2024
Sponsor: Ryazan State Medical University
Overall Status: Completed

Phase

N/A

Condition

Perimenopause

Circulation Disorders

Thrombosis

Treatment

Taking a person's venous blood

Clinical Study ID

NCT04943354
20-315-90017
  • Ages < 45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • male gender
  • age over 45 years

Study Design

Total Participants: 238
Treatment Group(s): 1
Primary Treatment: Taking a person's venous blood
Phase:
Study Start date:
September 01, 2020
Estimated Completion Date:
December 12, 2023

Study 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.

Connect with a study center

  • Sergey Vladimirovich Lopukhov

    Ryazan, Ryazan Region 390044
    Russian Federation

    Site Not Available

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