Primary Ovarian InsufficiencyNCT04943354
Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure
A study testing Taking a person's venous blood in people with Primary Ovarian Insufficiency and Cardiovascular Diseases, run by Ryazan State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Ovarian Insufficiency, Cardiovascular Diseases, Menopause, Premature
- What is being tested?
- Taking a person's venous blood
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2020to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- women under 45 years old
- presence of premature ovarian insufficiency in the medical history
Who cannot join
- male gender
- age over 45 years
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
Read the 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.
- Conditions
- Primary Ovarian Insufficiency, Cardiovascular Diseases, Menopause, Premature, Coronary Disease, Pulmonary Embolism, Arrhythmias, Cardiac
- Being tested
- Taking a person's venous blood
- 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
- Medical subject headings
- Primary Ovarian Insufficiency, Cardiovascular Diseases, Menopause, Premature, Coronary Disease, Pulmonary Embolism, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking a person's venous bloodBehavioural
Collection of 5 ml of the patient's venous blood, carried out according to standard rules.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Behavioral: Taking a person's venous blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age (years)
Patient age in years
Measured: 2 year
Secondary outcomes (1)
Menarche (years)
Age of onset of menarche expressed in years
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Sep 2020
- Primary completion3 Jun 2022
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943354
- Sponsor's protocol ID
- 20-315-90017
- Status last verified
- Jul 2022
- First submitted
- 27 Nov 2020
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04943354
- Acronym / sponsor ID
- 20-315-90017
- Conditions
- Primary Ovarian Insufficiency, Cardiovascular Diseases, Menopause, Premature, Coronary Disease, Pulmonary Embolism, Arrhythmias, Cardiac
- Keywords
- premature ovarian failure, hypoestrogenism, artificial menopause, cardiovascular disease, chronic non-infectious disease, cardiovascular outcomes, coronary heart disease, pulmonary embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study of single-nucleotide polymorphisms in women diagnosed with premature ovarian failure | Active comparator | Behavioral: Taking a person's venous bloodStudy 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. |
| Study of single-nucleotide polymorphisms in a control group of healthy women | Active comparator | Behavioral: Taking a person's venous bloodStudy 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 . |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- women under 45 years old
- presence of premature ovarian insufficiency in the medical history
Key exclusion criteria (2 listed)
- male gender
- age over 45 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taking a person's venous bloodCollection of 5 ml of the patient's venous blood, carried out according to standard rules. | Behavioural | Study of single-nucleotide polymorphisms in a control group of healthy women, Study of single-nucleotide polymorphisms in women diagnosed with premature ovarian failure |
Primary outcome
Age (years)
Time frame: 2 year
Patient age in years
1 secondary outcome
Menarche (years)
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taking a person's venous blood in people with Primary Ovarian Insufficiency and Cardiovascular Diseases, run by Ryazan State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (years) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.