Clusterin Level and Polycystic Ovary Syndrome

NCT ID: NCT06601725

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Clusterin, a protein involved in metabolic syndrome, insulin resistance, and metabolic disorders associated with inflammation and oxidative stress such as atherosclerosis, Alzheimer's and some malignancies, has elevated levels in metabolic syndrome, PCOS, and the combination of these two groups. Clusterin could be used as an inflammatory marker to predict PCOS and metabolic syndrome.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study included 118 women diagnosed with PCOS according to the Rotterdam criteria and 62 age-matched healthy women without cardiovascular risk factors. The patients diagnosed with PCOS were also classified into phenotypes. No interventional examination was requested for patients A, B, C, and D, except for hormonal tests and blood collection for Human Clusterin. The demographic and clinical characteristics of all patients were compared, with the primary outcome being blood Clusterin levels. The secondary outcomes are blood Clusterin levels in women with and without metabolic syndrome in addition to PCOS, the relationship between PCOS phenotypes and Clusterin levels, and the relationship between Clusterin levels and clinical and laboratory parameters.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome Ovulation Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phenotype A

Phenotype A was characterized by metabolic syndrome

Clusterin level

Intervention Type DIAGNOSTIC_TEST

Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis

Phenotype B

phenotype B was characterized by the absence of metabolic syndrome

Clusterin level

Intervention Type DIAGNOSTIC_TEST

Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis

Phenotype C

phenotype C was characterized by hyperandrogenism

Clusterin level

Intervention Type DIAGNOSTIC_TEST

Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis

Phenotype D

phenotype D was characterized by the absence of hyperandrogenism

Clusterin level

Intervention Type DIAGNOSTIC_TEST

Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clusterin level

Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women aged between 18 and 45,
* natural bilateral ovaries and no functional cysts on transvaginal ultrasound.

Exclusion Criteria

* who have hyperandrogenism/hyperandrogenemia
* who have non-classical congenital adrenal hyperplasia (17 OHP value \>2 nmol/L)
* who have thyroid disease (TSH \>5 mlU/L),
* women with hyperprolactinemia (Prolactin\>30 mlU/mL)
* patients taking hormonal drugs or ovulation induction agents.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanliurfa Mehmet Akif Inan Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nefise Nazlı YENIGUL

Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nefise Nazlı Yenigül

Bursa, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-KAEK-25 2021/02-06

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

REFUEL PCOS Study 1
NCT05973175 RECRUITING