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Comparison of Docosahexaenoic (DHA) Values in Patients With Polycystic Ovary Syndrome (PCOS)

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ClinicalTrials.gov Identifier: NCT05597111
Recruitment Status : Not yet recruiting
First Posted : October 27, 2022
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
Mehmet Kagitci, Recep Tayyip Erdogan University Training and Research Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Diagnostic Test: DHA levels of blood and cervical mucus

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Study Design
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Study Type : Observational
Estimated Enrollment : 138 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Docosahexaenoic Acid (DHA) Serum and Cervical Mucus Sample Values in Patients With Polycystic Ovary Syndrome (PCOS) and Control Group
Estimated Study Start Date : November 1, 2022
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Diagnostic Test: DHA levels of blood and cervical mucus
DHA levels of blood and cervical mucus of the control and the study groups will be measure
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
 Diagnostic Test: DHA levels of blood and cervical mucus
DHA levels of blood and cervical mucus of the control and the study groups will be measure


Outcome Measures
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Primary Outcome Measures :
  1. Blood DHA levels of patients with PCOS [ Time Frame: 3 months ]
    Blood DHA levels of patients with PCOS

  2. Cervical mucus DHA levels of patients with PCOS [ Time Frame: 3 months ]
    Cervical mucus DHA levels of patients with PCOS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
the patients diagnosed as PCOS according to Rotterdam criteria will be accepted as study group
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05597111


Contacts
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Contact: MEHMET KAGITCI 05053162890 mehmetkagitci1@hotmail.com

Locations
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Turkey
Recep Tayyip Erdogan Univercity
Rize, Turkey, 33090
Contact: MEHMET KAGITCI    05053162890    mehmetkagitci1@hotmail.com   
Sponsors and Collaborators
Recep Tayyip Erdogan University Training and Research Hospital
More Information
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Responsible Party: Mehmet Kagitci, Assistant professor, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05597111    
Other Study ID Numbers: 2022/183
First Posted: October 27, 2022    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Kagitci, Recep Tayyip Erdogan University Training and Research Hospital:
Polycystic Ovary Syndrome
Docosahexaenoic acid
inflammation
omega-3
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
 Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases