Skip to main content
OpenTrials
Completed

NCT Number: NCT04943354

Associations of Combinations of Single-nucleotide Polymorphisms 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Ovarian Insufficiency Adnexal Diseases Arrhythmias, Cardiac Cardiovascular Diseases Coronary Disease Embolism Embolism and Thrombosis Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Heart Diseases Lung Diseases Menopause, Premature Myocardial Ischemia Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Polymorphism, Single Nucleotide Pulmonary Embolism Respiratory Tract Diseases Urogenital Diseases Vascular Diseases

Age range

Up to 45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sergey Vladimirovich Lopukhov

Ryazan, Ryazan Oblast, 390044, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • male gender
  • age over 45 years

Treatment and study plan

Taking a person's venous blood

Behavioral

Collection of 5 ml of the patient's venous blood, carried out according to standard rules.

Primary outcomes

  1. Age (years)

    Time frame: 2 year

    Patient age in years

Secondary outcomes

  1. Menarche (years)

    Time frame: 2 year

    Age of onset of menarche expressed in years

Other outcomes

  1. Pregnancy (number)

    Time frame: 2 year

    Number of pregnancies in history

  2. Childbirth (number)

    Time frame: 2 year

    Number of pregnancies that ended in childbirth

  3. Menopause (yes/no)

    Time frame: 2 year

    Current presence or absence of menopause

  4. Surgical removal of both ovaries (yes/no)

    Time frame: 2 year

    History of surgery involving bilateral removal of both ovaries

  5. Presence of amenorrhoea (at least 4 months) (yes/no)

    Time frame: 2 year

    A history of amenorrhoea for at least 4 months

  6. Follicle stimulating hormone (FSH) level (mMed/ml)

    Time frame: 2 year

    Blood follicle-stimulating hormone content expressed in mMED/ml

  7. Age at menopause (years)

    Time frame: 2 year

    Age of onset of menopause

  8. Length of post-menopause (years)

    Time frame: 2 year

    How many years a person has been in the post-menopausal phase

  9. Taking oral contraceptives (yes/no)

    Time frame: 2 year

    Whether the patient is continuously taking oral contraceptives

  10. Taking hormone replacement therapy (HRT) (yes/no)

    Time frame: 2 year

    Whether the patient is taking regular hormone replacement therapy

  11. Length of time on hormone replacement therapy (years)

    Time frame: 2 year

    How long the patient has been on hormone replacement therapy

  12. Smoking status (yes/no)

    Time frame: 2 year

    Does the patient use nicotine-containing substances on a regular basis

  13. Number of cigarettes smoked per day (number)

    Time frame: 2 year

    How many cigarettes the patient smokes per day on average

  14. Smoking experience (years)

    Time frame: 2 year

    Number of years of active nicotine use by the patient

  15. Smoking index (points)

    Time frame: 2 year

    Calculated as the number of cigarettes smoked per day and years of smoking experience divided by 20.

  16. Height (cm)

    Time frame: 2 year

    Patient's height measured in centimetres

  17. Weight (kg)

    Time frame: 2 year

    Patient weight measured in kilograms

  18. BMI (kg/m2)

    Time frame: 2 year

    Body mass index is determined using the standard method

  19. Waist circumference (cm)

    Time frame: 2 year

    Waist circumference measured in centimetres using the standard method

  20. Hip circumference (cm)

    Time frame: 2 year

    Hip circumference measured in centimetres using the standard method

  21. Waist circumference to hip circumference ratio (WHR) (number)

    Time frame: 2 year

    Waist circumference to hip circumference index calculated using the standard method

  22. Secondary education (yes/no)

    Time frame: 2 year

    Does the patient have a high school education

  23. Secondary vocational education (yes/no)

    Time frame: 2 year

    Does the patient have a secondary vocational education

  24. Higher education (yes/no)

    Time frame: 2 year

    Does the patient have a university degree

  25. Systolic blood pressure (mmHg)

    Time frame: 2 year

    Systolic blood pressure measured using the standard method

  26. Diastolic blood pressure (mmHg)

    Time frame: 2 year

    Diastolic blood pressure measured using the standard method

  27. Heart rate (number)

    Time frame: 2 year

    Heart rate measured using the standard method

  28. Radial artery pulse (beats per minute).

    Time frame: 2 year

    Radial artery pulse measured using standard methods

  29. Arterial hypertension (yes/no)

    Time frame: 2 year

    History of arterial hypertension

  30. Ultrasound examination of the heart

    Time frame: 2 year

    Ultrasound examination of the heart carried out using standard methods to detect cardiac abnormalities

  31. Total cholesterol (mmol/l)

    Time frame: 2 year

    Total cholesterol measured by standard methods

  32. High-density lipoproteins (HDL) (mmol/l)

    Time frame: 2 year

    High-density lipoproteins measured by standard methods

  33. Low density lipoproteins LDL (mmol/l)

    Time frame: 2 year

    Low density lipoproteins measured by standard methods

  34. Triglycerides (mmol/l)

    Time frame: 2 year

    Triglycerides measured by standard methods

  35. Cholesterol/HDL ratio (number)

    Time frame: 2 year

    Calculated using the standard method

  36. Blood glucose level (mmol/l)

    Time frame: 2 year

    Amount of glucose in the blood measured by the standard method

  37. Glycated haemoglobin (HbA1c), (percent %)

    Time frame: 2 year

    Glycated haemoglobin measured by standard methods

  38. Diabetes mellitus (yes/no)

    Time frame: 2 year

    Indication of diabetes mellitus in the patient's medical history

  39. Taking antihypertensive medication (yes/no)

    Time frame: 2 year

    Indication of antihypertensive medication in the patient's medical history

  40. Taking hypolipidemic medicines (yes/no)

    Time frame: 2 year

    Use of hypolipidemic drugs in a patient's history

  41. Metabolic syndrome (yes/no)

    Time frame: 2 year

    Indicating a history of metabolic syndrome

  42. 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

  43. 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

  44. 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

  45. Presence of post-menopausal diagnosis: thromboembolism (yes/no)

    Time frame: 2 year

    Post-menopausal diagnosis of thromboembolism based on medical history

  46. 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

  47. 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

  48. 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

  49. A history of cancer (yes/no)

    Time frame: 2 year

    Determined on the basis of the medical history

  50. AGT gene Met235Thr, rs699 polymorphism

    Time frame: 2 year

    Identification of Met235Thr/rs699 polymorphisms in the AGT gene

  51. 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

  52. NOS3 gene C786T, rs2070744 polymorphism

    Time frame: 2 year

    Identification of C786T, rs2070744 polymorphisms in the NOS3 gene

  53. EDN1 gene Lys198Asn, rs5370 polymorphism

    Time frame: 2 year

    Identification of Lys198Asn, rs5370 polymorphisms in the EDN1 gene

  54. ITGB3 gene Leu33Pro, rs5918 polymorphism

    Time frame: 2 year

    Identification of Leu33Pro, rs5918 polymorphisms in the ITGB3 gene

  55. ITGA2 gene C807T, rs1126643 polymorphism

    Time frame: 2 year

    Identification of C807T, rs1126643 polymorphisms in the ITGA2 gene

  56. FGB gene 455G-A, rs1800790 polymorphism

    Time frame: 2 year

    Identification of 455G-A, rs1800790 polymorphisms in the FGB gene

  57. 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

  58. CRP gene C3872T, rs1205 polymorphism

    Time frame: 2 year

    Identification of C3872T, rs1205 polymorphisms in the CRP gene

  59. IL17A gene G-197A, rs2275913 polymorphism

    Time frame: 2 year

    Identification of G-197A, rs2275913 polymorphisms in the IL17A gene

  60. IL2 gene T-330G, rs2069762 polymorphism

    Time frame: 2 year

    Identification of T-330G, rs2069762 polymorphisms in the IL2 gene

  61. IL10 gene C-592A, rs1800872 polymorphism

    Time frame: 2 year

    Identification of C-592A, rs1800872 polymorphisms in the IL10 gene

  62. TNF gene G-308A, rs1800629 polymorphism

    Time frame: 2 year

    Identification of G-308A, rs1800629 polymorphisms in the TNF gene

  63. CRP gene A-717G, rs2794521 polymorphism

    Time frame: 2 year

    Identification of A-717G, rs2794521 polymorphisms in the CRP gene

  64. IL6 gene C-174G, rs1800795 polymorphism

    Time frame: 2 year

    Identification of C-174G, rs1800795 polymorphisms in the IL6 gene

  65. TLR2 gene Arg753Gln, rs5743708 polymorphism

    Time frame: 2 year

    Identification of Arg753Gln, rs5743708 polymorphisms in the TLR2 gene

  66. TLR3 gene Phe412Leu, rs3775291 polymorphism

    Time frame: 2 year

    Identification of Phe412Leu, rs3775291 polymorphisms in the TLR3 gene

  67. TLR4 gene Asp299Gly, rs4986790 polymorphism

    Time frame: 2 year

    Identification of Asp299Gly, rs4986790 polymorphisms in the TLR4 gene

  68. TLR6 gene Ser249Pro, rs5743810 polymorphism

    Time frame: 2 year

    Identification of Ser249Pro, rs5743810 polymorphisms in the TLR6 gene

  69. TLR9 gene T-1237C, rs5743836 polymorphism

    Time frame: 2 year

    Identification of T-1237C, rs5743836 polymorphisms in the TLR9 gene

Sponsors and collaborators

Lead sponsor

Ryazan State Medical University

Other

Registry information

Official study title

Associations of Combinations of Single-nucleotide Polymorphisms and Behavioural Risk Factors With Non-communicable Diseases and Adverse Outcomes in Women With Premature Ovarian Failure

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 29, 2021
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.