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

NCT04943354 | Completed

• 1 other identifier: 20-315-90017
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

premature ovarian failure; hypoestrogenism; artificial menopause; cardiovascular disease; chronic non-infectious disease; cardiovascular outcomes; coronary heart disease; pulmonary embolism; cardiac arrhythmias; heart rhythm disturbances; single nucleotide polymorphisms

Outcome Measures

Primary Outcomes (1)

• Age (years)

  Patient age in years

  2 year

Secondary Outcomes (1)

• Menarche (years)

  2 year

Other Outcomes (69)

• Pregnancy (number)

  2 year

• Childbirth (number)

  2 year

• Menopause (yes/no)

  2 year

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Behavioral: Taking a person's venous blood

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

ACTIVE COMPARATOR

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 .

Behavioral: Taking a person's venous blood

Interventions

Taking a person's venous blood BEHAVIORAL

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

Study of single-nucleotide polymorphisms in a control group of healthy women; Study of single-nucleotide polymorphisms in women diagnosed with premature ovarian failure

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• male gender
• age over 45 years

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (1)

Sergey Vladimirovich Lopukhov

Ryazan, Ryazan Oblast, 390044, Russia

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency; Cardiovascular Diseases; Menopause, Premature; Coronary Disease; Pulmonary Embolism; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women diagnosed with premature ovarian failure were selected from different medical institutions in Ryazan and the Ryazan region, all information was communicated to them in a clear and understandable way and they also signed an informed voluntary consent. Premature ovarian failure - defined as the occurrence of secondary amenorrhoea ≥4 months at the age of under 45 years together with FSH levels above 40 IU/L. Inclusion criteria were: female gender, age at menopause \< 45 years, onset of secondary amenorrhoea ≥ 4 months, FSH levels higher than 40 IU/l, or a previous diagnosis of premature ovarian failure. The control group was formed based on comparability criteria of gender, age and BMI to minimise the influence of phenotype on the results. The control group consisted of women without signs of PEN, so we aimed to compare the health status of these two different groups of women.

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: June 29, 2021
• Study Start: September 1, 2020
• Primary Completion: June 3, 2022
• Study Completion: December 12, 2023
• Last Updated: March 12, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)