Polycystic Ovary SyndromeNCT05597111
Comparison of Docosahexaenoic (DHA) Values in Patients With Polycystic Ovary Syndrome (PCOS)
An observational study of Polycystic Ovary Syndrome, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although PCOS has been known for many years, its etiology and treatment are not clearly known. The prevalence of PCOS varies between populations. It is a familial endocrinolpathology with a chronic course, multifactorial, polygenic feature seen with an average prevalence of 6-8% in women in the reproductive… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- DHA levels of blood and cervical mucus
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Feb 2023
- Phase
- Observational
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: the patients diagnosed as PCOS according to Rotterdam criteria will be accepted as study group
Who may be able to join
- 1- Patients with polycystic ovary syndrome
Who cannot join
- Pregnancy
- Malignity
- postmenopause
- diagnosis of congenital adrenal syndrome
- Oral contraseptive use at last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan Univercity
Rize, 33090
MEHMET KAGITCI, 05053162890, mehmetkagitci1@hotmail.com
About this study
Official title: Comparison of Docosahexaenoic Acid (DHA) Serum and Cervical Mucus Sample Values in Patients With Polycystic Ovary Syndrome (PCOS) and Control Group
Although PCOS has been known for many years, its etiology and treatment are not clearly known. The prevalence of PCOS varies between populations. It is a familial endocrinolpathology with a chronic course, multifactorial, polygenic feature seen with an average prevalence of 6-8% in women in the reproductive period.Chronic inflammation is involved in the pathophysiology of many chronic diseases. PCOS, which is a proinflammatory condition, has been associated with insulin resistance and hyperandrogenism in previous studies.
Omega-3 fatty acids have anti-inflammatory, anti-thrombotic, anti-arrhythmic properties, reducing lipid levels such as serum triglyceride and LDL cholesterol, and having positive effects on the immune system. Therefore, their deficiencies include fatigue, joint pain, frequent infections, etc. is seen. Omega-6 fatty acids have the opposite effect.
Read more
DHA is a member of the omega-3 fatty acids family. Dietary components play an important role in chronic inflammation.
According to our literature review, there is no study that detects docosahexaenoic acid (DHA) levels in blood and cervical mucus samples in patients with PCOS. We think that we will contribute to the diagnosis and treatment processes of PCOS patients by detecting DHA levels in this study.
In this study, we aim to compare the values of docosahexaenoic acid (DHA) in serum and cervical mucus samples in patients with polycystic ovary syndrome with the control group.
Read the detailed description
Polycystic ovary syndrome (PCOS) was first described in 1935 by Dr. Stein and Dr. It was defined by Leventhal. Although PCOS has been known for many years, its etiology and treatment are not clearly known. The prevalence of PCOS varies between populations. It is a familial endocrinolpathology with a chronic course, multifactorial, and polygenic features, with an average prevalence of 6-8% in women in the reproductive period. PCOS is a symptom complex that requires a multidisciplinary approach involving many departments. The clinic in PCOS progresses with different symptoms in each patient. In general, such as menstrual irregularities, alopecia due to androgen excess, acne, hirsutism, infertility, obesity, abnormal lipid levels, glucose intolerance, acanthosis nigricans, Type 2 diabetes, endometrial hyperplasia, endometrial cancer, ovarian cancer, breast cancer, hypertension, coronary heart diseases. It progresses with mood changes ,cardiovascular diseases, abortion, IUGR, depression, anxiety, eating disorders, and obstructive sleep apnea. Determining the diagnostic criteria for PCOS is important in terms of long-term risks rather than short-term effects in patients. PCOS diagnostic criteria were divided into different categories in 3 different periods. For the first time, 3 important criteria were determined in the National Institutes of Health Criteria (NICHD) in 1990. (1)menstrual dysfunction (oligo/anovulation), (2) hyperandrogenism/hyperandrogenemia (hirsutism, acne, androgenetic alopecia), (3) causes mimicking similar clinics should be excluded. Rotterdam Consensus Criteria was determined in 2003 for the second time in the diagnosis of PCOS. Rotterdam Criteria At least 2 of the 3 major criteria must be present. The first criterion is (1) menstrual dysfunction (oligo/anovulation), (2) hyperandrogenism/hyperandrogenemia (hirsutism, acne, androgenetic alopecia), (3) polycystic ovarian morphology in ultrasonography (at least one ovary with 12 or more follicles 2-9 mm in diameter) and ovarian volume of 10 ml or more) and similar clinical mimicking causes should be excluded. Third are the Androgen Excess Society (AE-PCOS) criteria made in 2006. The criteria should be (1) menstrual dysfunction (oligo/anovulation), (2) hyperandrogenism/hyperandrogenemia (hirsutism, acne, androgenetic alopecia), (3) polycystic ovary appearance on ultrasonography, and (a) causes mimicking similar clinics. 1 and 2 or 2 and 3 conditions were determined from these criteria.
Chronic inflammation is involved in the pathophysiology of many chronic diseases. PCOS, which is a proinflammatory condition, has been associated with insulin resistance and hyperandrogenism in previous studies.
All fats play important roles in energy metabolism and body functions; however, the omega-6 precursor, linoleic acid (LA), and the omega-3 precursor, alpha-linolenic acid (ALA), are known as essential fatty acids because they cannot be synthesized in the body and therefore become a vital component of a healthy diet. These are unsaturated fatty acids with double bonds between carbon atoms, unlike saturated fatty acids, where all carbon atoms are "saturated" with hydrogen atoms. Depending on the position of the double bond with respect to the methyl end carbon (omega carbon), unsaturated fatty acids are classified as omega-3 and omega-6 fatty acids. Omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) contain alpha- it is derived from linolenic acid (ALA) .
Omega-3 fatty acids have anti-inflammatory, anti-thrombotic, anti-arrhythmic properties, reducing lipid levels such as serum triglyceride and LDL cholesterol, and having positive effects on the immune system. Therefore, their deficiencies include fatigue, joint pain, frequent infections, etc. is seen. Omega-6 fatty acids have the opposite effect.
DHA is a member of the omega-3 fatty acids family. Dietary components play an important role in chronic inflammation. It has been reported that a diet rich in omega-3 fatty acids may have positive effects on epigenomes. It has been shown that inflammatory cytokines such as interleukin 1-β, thromboxane A2, interleukin-6, tumor necrosis factor, leukotriene B and C-reactive protein increase in chronic diseases. In particular, the anti-inflammatory effects of omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been reported.
There are studies showing that some inflammatory substances in the endometrial washings of PCOS patients are different from the normal population . These studies suggest that inflammation may also be a cause of common infertility in PCOS patients by affecting endometrial receptivity.
According to our literature review, there is no study that detects docosahexaenoic acid (DHA) levels in blood and cervical mucus samples in patients with PCOS. We think that we will contribute to the diagnosis and treatment processes of PCOS patients by detecting DHA levels in this study.
In this study, we aim to compare the values of docosahexaenoic acid (DHA) in serum and cervical mucus samples in patients with polycystic ovary syndrome with the control group.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- DHA levels of blood and cervical mucus
- Keywords
- Polycystic Ovary Syndrome, Docosahexaenoic acid, inflammation, omega-3
- Medical subject headings
- Polycystic Ovary Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA levels of blood and cervical mucusDiagnostic test
DHA levels of blood and cervical mucus of the control and the study groups will be measure
| Study group | Role | What they receive |
|---|---|---|
| Blood DHA levels of patients with PCOS | The patients diagnosed as PCOS according to Rotterdam criteria will be the study group. The DHA leves in blood sample of the patients will be recorded Receives: Diagnostic Test: DHA levels of blood and cervical mucus | |
| BloodDHA levels of the control group | The patients without PCOS will be control group. The DHA leves in blood sample of the patients will be recorded Receives: Diagnostic Test: DHA levels of blood and cervical mucus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood DHA levels of patients with PCOS
Blood DHA levels of patients with PCOS
Measured: 3 months
Cervical mucus DHA levels of patients with PCOS
Cervical mucus DHA levels of patients with PCOS
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kagitci, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597111
- Sponsor's protocol ID
- 2022/183
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Docosahexaenoic Acid (DHA) Serum and Cervical Mucus Sample Values in Patients With Polycystic Ovary Syndrome (PCOS) and Control Group
- ClinicalTrials.gov ID
- NCT05597111
- Acronym / sponsor ID
- 2022/183
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Docosahexaenoic acid, inflammation, omega-3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 27 Oct 2022 (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.
Although PCOS has been known for many years, its etiology and treatment are not clearly known. The prevalence of PCOS varies between populations. It is a familial endocrinolpathology with a chronic course, multifactorial, polygenic feature seen with an average prevalence of 6-8% in women in the reproductive period.Chronic inflammation is involved in the pathophysiology of many chronic diseases. PCOS, which is a proinflammatory condition, has been associated with insulin resistance and hyperandrogenism in previous studies.
Omega-3 fatty acids have anti-inflammatory, anti-thrombotic, anti-arrhythmic properties, reducing lipid levels such as serum triglyceride and LDL cholesterol, and having positive effects on the immune system. Therefore, their deficiencies include fatigue, joint pain, frequent infections, etc. is seen. Omega-6 fatty acids have the opposite effect.
DHA is a member of the omega-3 fatty acids family. Dietary components play an important role in chronic inflammation.
According to our literature review, there is no study that detects docosahexaenoic acid (DHA) levels in blood and cervical mucus samples in patients with PCOS. We think that we will contribute to the diagnosis and treatment processes of PCOS patients by detecting DHA levels in this study.
In this study, we aim to compare the values of docosahexaenoic acid (DHA) in serum and cervical mucus samples in patients with polycystic ovary syndrome with the control group.
Detailed description
Polycystic ovary syndrome (PCOS) was first described in 1935 by Dr. Stein and Dr. It was defined by Leventhal. Although PCOS has been known for many years, its etiology and treatment are not clearly known. The prevalence of PCOS varies between populations. It is a familial endocrinolpathology with a chronic course, multifactorial, and polygenic features, with an average prevalence of 6-8% in women in the reproductive period. PCOS is a symptom complex that requires a multidisciplinary approach involving many departments. The clinic in PCOS progresses with different symptoms in each patient. In general, such as menstrual irregularities, alopecia due to androgen excess, acne, hirsutism, infertility, obesity, abnormal lipid levels, glucose intolerance, acanthosis nigricans, Type 2 diabetes, endometrial hyperplasia, endometrial cancer, ovarian cancer, breast cancer, hypertension, coronary heart diseases. It progresses with mood changes ,cardiovascular diseases, abortion, IUGR, depression, anxiety, eating disorders, and obstructive sleep apnea. Determining the diagnostic criteria for PCOS is important in terms of long-term risks rather than short-term effects in patients. PCOS diagnostic criteria were divided into different categories in 3 different periods. For the first time, 3 important criteria were determined in the National Institutes of Health Criteria (NICHD) in 1990. (1)menstrual dysfunction (oligo/anovulation), (2) hyperandrogenism/hyperandrogenemia (hirsutism, acne, androgenetic alopecia), (3) causes mimicking similar clinics should be excluded. Rotterdam Consensus Criteria was determined in 2003 for the second time in the diagnosis of PCOS. Rotterdam Criteria At least 2 of the 3 major criteria must be present. The first criterion is (1) menstrual dysfunction (oligo/anovulation), (2) hyperandrogenism/hyperandrogenemia (hirsutism, acne, androgenetic alopecia), (3) polycystic ovarian morphology in ultrasonography (at least one ovary with 12 or more follicles 2-9 mm in diameter) and ovarian volume of 10 ml or more) and similar clinical mimicking causes should be excluded. Third are the Androgen Excess Society (AE-PCOS) criteria made in 2006. The criteria should be (1) menstrual dysfunction (oligo/anovulation), (2) hyperandrogenism/hyperandrogenemia (hirsutism, acne, androgenetic alopecia), (3) polycystic ovary appearance on ultrasonography, and (a) causes mimicking similar clinics. 1 and 2 or 2 and 3 conditions were determined from these criteria.
Chronic inflammation is involved in the pathophysiology of many chronic diseases. PCOS, which is a proinflammatory condition, has been associated with insulin resistance and hyperandrogenism in previous studies.
All fats play important roles in energy metabolism and body functions; however, the omega-6 precursor, linoleic acid (LA), and the omega-3 precursor, alpha-linolenic acid (ALA), are known as essential fatty acids because they cannot be synthesized in the body and therefore become a vital component of a healthy diet. These are unsaturated fatty acids with double bonds between carbon atoms, unlike saturated fatty acids, where all carbon atoms are "saturated" with hydrogen atoms. Depending on the position of the double bond with respect to the methyl end carbon (omega carbon), unsaturated fatty acids are classified as omega-3 and omega-6 fatty acids. Omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) contain alpha- it is derived from linolenic acid (ALA) .
Omega-3 fatty acids have anti-inflammatory, anti-thrombotic, anti-arrhythmic properties, reducing lipid levels such as serum triglyceride and LDL cholesterol, and having positive effects on the immune system. Therefore, their deficiencies include fatigue, joint pain, frequent infections, etc. is seen. Omega-6 fatty acids have the opposite effect.
DHA is a member of the omega-3 fatty acids family. Dietary components play an important role in chronic inflammation. It has been reported that a diet rich in omega-3 fatty acids may have positive effects on epigenomes. It has been shown that inflammatory cytokines such as interleukin 1-β, thromboxane A2, interleukin-6, tumor necrosis factor, leukotriene B and C-reactive protein increase in chronic diseases. In particular, the anti-inflammatory effects of omega-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been reported.
There are studies showing that some inflammatory substances in the endometrial washings of PCOS patients are different from the normal population . These studies suggest that inflammation may also be a cause of common infertility in PCOS patients by affecting endometrial receptivity.
According to our literature review, there is no study that detects docosahexaenoic acid (DHA) levels in blood and cervical mucus samples in patients with PCOS. We think that we will contribute to the diagnosis and treatment processes of PCOS patients by detecting DHA levels in this study.
In this study, we aim to compare the values of docosahexaenoic acid (DHA) in serum and cervical mucus samples in patients with polycystic ovary syndrome with the control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood DHA levels of patients with PCOS | – | Diagnostic Test: DHA levels of blood and cervical mucusThe patients diagnosed as PCOS according to Rotterdam criteria will be the study group. The DHA leves in blood sample of the patients will be recorded |
| BloodDHA levels of the control group | – | Diagnostic Test: DHA levels of blood and cervical mucusThe patients without PCOS will be control group. The DHA leves in blood sample of the patients will be recorded |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- the patients diagnosed as PCOS according to Rotterdam criteria will be accepted as study group
Key inclusion criteria (1 listed)
- 1- Patients with polycystic ovary syndrome
Key exclusion criteria (5 listed)
- Pregnancy
- Malignity
- postmenopause
- diagnosis of congenital adrenal syndrome
- Oral contraseptive use at last 3 months
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 |
|---|---|---|
| DHA levels of blood and cervical mucusDHA levels of blood and cervical mucus of the control and the study groups will be measure | Diagnostic test | Blood DHA levels of patients with PCOS, BloodDHA levels of the control group |
Primary outcome
Blood DHA levels of patients with PCOS
Time frame: 3 months
Blood DHA levels of patients with PCOS
Cervical mucus DHA levels of patients with PCOS
Time frame: 3 months
Cervical mucus DHA levels of patients with PCOS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Oct 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MEHMET KAGITCI (05053162890, mehmetkagitci1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood DHA levels of patients with PCOS (time frame: 3 months). The study lists 2 primary outcomes in all. 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 27 Oct 2022.