- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04943354
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ryazan Region
-
Ryazan, Ryazan Region, Russian Federation, 390044
- Sergey Vladimirovich Lopukhov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Study of single-nucleotide polymorphisms in women diagnosed with premature ovarian failure
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.
|
Collection of 5 ml of the patient's venous blood, carried out according to standard rules.
|
Active Comparator: Study of single-nucleotide polymorphisms in a control group of healthy women
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 .
|
Collection of 5 ml of the patient's venous blood, carried out according to standard rules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age (years)
Time Frame: 2 year
|
Patient age in years
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Menarche (years)
Time Frame: 2 year
|
Age of onset of menarche expressed in years
|
2 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy (number)
Time Frame: 2 year
|
Number of pregnancies in history
|
2 year
|
Childbirth (number)
Time Frame: 2 year
|
Number of pregnancies that ended in childbirth
|
2 year
|
Menopause (yes/no)
Time Frame: 2 year
|
Current presence or absence of menopause
|
2 year
|
Surgical removal of both ovaries (yes/no)
Time Frame: 2 year
|
History of surgery involving bilateral removal of both ovaries
|
2 year
|
Presence of amenorrhoea (at least 4 months) (yes/no)
Time Frame: 2 year
|
A history of amenorrhoea for at least 4 months
|
2 year
|
Follicle stimulating hormone (FSH) level (mMed/ml)
Time Frame: 2 year
|
Blood follicle-stimulating hormone content expressed in mMED/ml
|
2 year
|
Age at menopause (years)
Time Frame: 2 year
|
Age of onset of menopause
|
2 year
|
Length of post-menopause (years)
Time Frame: 2 year
|
How many years a person has been in the post-menopausal phase
|
2 year
|
Taking oral contraceptives (yes/no)
Time Frame: 2 year
|
Whether the patient is continuously taking oral contraceptives
|
2 year
|
Taking hormone replacement therapy (HRT) (yes/no)
Time Frame: 2 year
|
Whether the patient is taking regular hormone replacement therapy
|
2 year
|
Length of time on hormone replacement therapy (years)
Time Frame: 2 year
|
How long the patient has been on hormone replacement therapy
|
2 year
|
Smoking status (yes/no)
Time Frame: 2 year
|
Does the patient use nicotine-containing substances on a regular basis
|
2 year
|
Number of cigarettes smoked per day (number)
Time Frame: 2 year
|
How many cigarettes the patient smokes per day on average
|
2 year
|
Smoking experience (years)
Time Frame: 2 year
|
Number of years of active nicotine use by the patient
|
2 year
|
Smoking index (points)
Time Frame: 2 year
|
Calculated as the number of cigarettes smoked per day and years of smoking experience divided by 20.
|
2 year
|
Height (cm)
Time Frame: 2 year
|
Patient's height measured in centimetres
|
2 year
|
Weight (kg)
Time Frame: 2 year
|
Patient weight measured in kilograms
|
2 year
|
BMI (kg/m2)
Time Frame: 2 year
|
Body mass index is determined using the standard method
|
2 year
|
Waist circumference (cm)
Time Frame: 2 year
|
Waist circumference measured in centimetres using the standard method
|
2 year
|
Hip circumference (cm)
Time Frame: 2 year
|
Hip circumference measured in centimetres using the standard method
|
2 year
|
Waist circumference to hip circumference ratio (WHR) (number)
Time Frame: 2 year
|
Waist circumference to hip circumference index calculated using the standard method
|
2 year
|
Secondary education (yes/no)
Time Frame: 2 year
|
Does the patient have a high school education
|
2 year
|
Secondary vocational education (yes/no)
Time Frame: 2 year
|
Does the patient have a secondary vocational education
|
2 year
|
Higher education (yes/no)
Time Frame: 2 year
|
Does the patient have a university degree
|
2 year
|
Systolic blood pressure (mmHg)
Time Frame: 2 year
|
Systolic blood pressure measured using the standard method
|
2 year
|
Diastolic blood pressure (mmHg)
Time Frame: 2 year
|
Diastolic blood pressure measured using the standard method
|
2 year
|
Heart rate (number)
Time Frame: 2 year
|
Heart rate measured using the standard method
|
2 year
|
Radial artery pulse (beats per minute).
Time Frame: 2 year
|
Radial artery pulse measured using standard methods
|
2 year
|
Arterial hypertension (yes/no)
Time Frame: 2 year
|
History of arterial hypertension
|
2 year
|
Ultrasound examination of the heart
Time Frame: 2 year
|
Ultrasound examination of the heart carried out using standard methods to detect cardiac abnormalities
|
2 year
|
Total cholesterol (mmol/l)
Time Frame: 2 year
|
Total cholesterol measured by standard methods
|
2 year
|
High-density lipoproteins (HDL) (mmol/l)
Time Frame: 2 year
|
High-density lipoproteins measured by standard methods
|
2 year
|
Low density lipoproteins LDL (mmol/l)
Time Frame: 2 year
|
Low density lipoproteins measured by standard methods
|
2 year
|
Triglycerides (mmol/l)
Time Frame: 2 year
|
Triglycerides measured by standard methods
|
2 year
|
Cholesterol/HDL ratio (number)
Time Frame: 2 year
|
Calculated using the standard method
|
2 year
|
Blood glucose level (mmol/l)
Time Frame: 2 year
|
Amount of glucose in the blood measured by the standard method
|
2 year
|
Glycated haemoglobin (HbA1c), (percent %)
Time Frame: 2 year
|
Glycated haemoglobin measured by standard methods
|
2 year
|
Diabetes mellitus (yes/no)
Time Frame: 2 year
|
Indication of diabetes mellitus in the patient's medical history
|
2 year
|
Taking antihypertensive medication (yes/no)
Time Frame: 2 year
|
Indication of antihypertensive medication in the patient's medical history
|
2 year
|
Taking hypolipidemic medicines (yes/no)
Time Frame: 2 year
|
Use of hypolipidemic drugs in a patient's history
|
2 year
|
Metabolic syndrome (yes/no)
Time Frame: 2 year
|
Indicating a history of metabolic syndrome
|
2 year
|
Presence of post-menopausal diagnosis: arrhythmia or other rhythm disturbances (yes/no)
Time Frame: 2 year
|
Post-menopausal diagnosis of arrhythmia or other rhythm disturbances based on medical history
|
2 year
|
Presence of a post-menopausal diagnosis of coronary heart disease (yes/no)
Time Frame: 2 year
|
Presence of post-menopausal diagnosis of coronary heart disease according to medical history
|
2 year
|
Presence of a post-menopausal diagnosis of myocardial infarction (yes/no)
Time Frame: 2 year
|
Post-menopausal diagnosis of myocardial infarction based on medical history
|
2 year
|
Presence of post-menopausal diagnosis: thromboembolism (yes/no)
Time Frame: 2 year
|
Post-menopausal diagnosis of thromboembolism based on medical history
|
2 year
|
Post-menopausal diagnosis of varicose veins in the lower limbs (yes/no)
Time Frame: 2 year
|
Post-menopausal diagnosis of varicose veins in the lower limbs based on medical history
|
2 year
|
Presence of a post-menopausal diagnosis: Acute cerebral haemorrhage (yes/no)
Time Frame: 2 year
|
Post-menopausal diagnosis of acute cerebral haemorrhage on medical history
|
2 year
|
Deaths from cardiovascular disease in the post-menopausal period (yes/no)
Time Frame: 2 year
|
Cardiovascular deaths in the post-menopausal period based on the pathologist's medical history report
|
2 year
|
A history of cancer (yes/no)
Time Frame: 2 year
|
Determined on the basis of the medical history
|
2 year
|
AGT gene Met235Thr, rs699 polymorphism
Time Frame: 2 year
|
Identification of Met235Thr/rs699 polymorphisms in the AGT gene
|
2 year
|
ACE gene Alu Ins/Del I>D, rs4646994 polymorphism
Time Frame: 2 year
|
Identification of Alu Ins/Del I>D, rs4646994 polymorphisms in the ACE gene
|
2 year
|
NOS3 gene C786T, rs2070744 polymorphism
Time Frame: 2 year
|
Identification of C786T, rs2070744 polymorphisms in the NOS3 gene
|
2 year
|
EDN1 gene Lys198Asn, rs5370 polymorphism
Time Frame: 2 year
|
Identification of Lys198Asn, rs5370 polymorphisms in the EDN1 gene
|
2 year
|
ITGB3 gene Leu33Pro, rs5918 polymorphism
Time Frame: 2 year
|
Identification of Leu33Pro, rs5918 polymorphisms in the ITGB3 gene
|
2 year
|
ITGA2 gene C807T, rs1126643 polymorphism
Time Frame: 2 year
|
Identification of C807T, rs1126643 polymorphisms in the ITGA2 gene
|
2 year
|
FGB gene 455G-A, rs1800790 polymorphism
Time Frame: 2 year
|
Identification of 455G-A, rs1800790 polymorphisms in the FGB gene
|
2 year
|
SERPINE (PAI) 1 gene 675 5G/4G, rs1799768 polymorphism
Time Frame: 2 year
|
Identification of 675 5G/4G, rs1799768 polymorphisms in the SERPINE (PAI) 1 gene
|
2 year
|
CRP gene C3872T, rs1205 polymorphism
Time Frame: 2 year
|
Identification of C3872T, rs1205 polymorphisms in the CRP gene
|
2 year
|
IL17A gene G-197A, rs2275913 polymorphism
Time Frame: 2 year
|
Identification of G-197A, rs2275913 polymorphisms in the IL17A gene
|
2 year
|
IL2 gene T-330G, rs2069762 polymorphism
Time Frame: 2 year
|
Identification of T-330G, rs2069762 polymorphisms in the IL2 gene
|
2 year
|
IL10 gene C-592A, rs1800872 polymorphism
Time Frame: 2 year
|
Identification of C-592A, rs1800872 polymorphisms in the IL10 gene
|
2 year
|
TNF gene G-308A, rs1800629 polymorphism
Time Frame: 2 year
|
Identification of G-308A, rs1800629 polymorphisms in the TNF gene
|
2 year
|
CRP gene A-717G, rs2794521 polymorphism
Time Frame: 2 year
|
Identification of A-717G, rs2794521 polymorphisms in the CRP gene
|
2 year
|
IL6 gene C-174G, rs1800795 polymorphism
Time Frame: 2 year
|
Identification of C-174G, rs1800795 polymorphisms in the IL6 gene
|
2 year
|
TLR2 gene Arg753Gln, rs5743708 polymorphism
Time Frame: 2 year
|
Identification of Arg753Gln, rs5743708 polymorphisms in the TLR2 gene
|
2 year
|
TLR3 gene Phe412Leu, rs3775291 polymorphism
Time Frame: 2 year
|
Identification of Phe412Leu, rs3775291 polymorphisms in the TLR3 gene
|
2 year
|
TLR4 gene Asp299Gly, rs4986790 polymorphism
Time Frame: 2 year
|
Identification of Asp299Gly, rs4986790 polymorphisms in the TLR4 gene
|
2 year
|
TLR6 gene Ser249Pro, rs5743810 polymorphism
Time Frame: 2 year
|
Identification of Ser249Pro, rs5743810 polymorphisms in the TLR6 gene
|
2 year
|
TLR9 gene T-1237C, rs5743836 polymorphism
Time Frame: 2 year
|
Identification of T-1237C, rs5743836 polymorphisms in the TLR9 gene
|
2 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Embolism and Thrombosis
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Coronary Disease
- Cardiovascular Diseases
- Embolism
- Premature Birth
- Arrhythmias, Cardiac
- Primary Ovarian Insufficiency
- Menopause, Premature
- Pulmonary Embolism
Other Study ID Numbers
- 20-315-90017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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