Trial Title:
Comparison of Docosahexaenoic (DHA) Values in Patients With Polycystic Ovary Syndrome (PCOS)
NCT ID:
NCT05597111
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Conditions: Keywords:
Polycystic Ovary Syndrome
Docosahexaenoic acid
inflammation
omega-3
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
DHA levels of blood and cervical mucus
Description:
DHA levels of blood and cervical mucus of the control and the study groups will be
measure
Arm group label:
Blood DHA levels of patients with PCOS
Arm group label:
BloodDHA levels of the control group
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 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.
Criteria for eligibility:
Study pop:
the patients diagnosed as PCOS according to Rotterdam criteria will be accepted as study
group
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1- Patients with polycystic ovary syndrome
Exclusion Criteria:
1. Pregnancy
2. Malignity
3. postmenopause
4. diagnosis of congenital adrenal syndrome
5. Oral contraseptive use at last 3 months
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Recep Tayyip Erdogan Univercity
Address:
City:
Rize
Zip:
33090
Country:
Turkey
Contact:
Last name:
MEHMET KAGITCI
Phone:
05053162890
Email:
mehmetkagitci1@hotmail.com
Start date:
November 1, 2022
Completion date:
February 1, 2023
Lead sponsor:
Agency:
Recep Tayyip Erdogan University Training and Research Hospital
Agency class:
Other
Source:
Recep Tayyip Erdogan University Training and Research Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05597111
