NCT05597111

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

October 24, 2022

Last Update Submit

October 24, 2022

Conditions

Keywords

Polycystic Ovary SyndromeDocosahexaenoic acidinflammationomega-3

Outcome Measures

Primary Outcomes (2)

  • Blood DHA levels of patients with PCOS

    Blood DHA levels of patients with PCOS

    3 months

  • Cervical mucus DHA levels of patients with PCOS

    Cervical mucus DHA levels of patients with PCOS

    3 months

Study Arms (2)

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

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

Interventions

DHA levels of blood and cervical mucus of the control and the study groups will be measure

Blood DHA levels of patients with PCOSBloodDHA levels of the control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

the patients diagnosed as PCOS according to Rotterdam criteria will be accepted as study group

You may qualify if:

  • Patients with polycystic ovary syndrome

You may not qualify if:

  • Pregnancy
  • Malignity
  • postmenopause
  • diagnosis of congenital adrenal syndrome
  • Oral contraseptive use at last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan Univercity

Rize, 33090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInflammation

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 27, 2022

Study Start

November 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

October 27, 2022

Record last verified: 2022-10

Locations