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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05597111
Study groupRoleWhat they receive
Blood DHA levels of patients with PCOSThe 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 groupThe 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.

  1. Blood DHA levels of patients with PCOS

    Blood DHA levels of patients with PCOS

    Measured: 3 months

  2. 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.

  1. First posted27 Oct 2022
  2. Study start1 Nov 2022 (estimated)
  3. Primary completion1 Feb 2023 (estimated)
  4. Study completion1 Feb 2023 (estimated)

Resources

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)
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

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.

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