Clusterin Level and Polycystic Ovary Syndrome

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Status: Completed

Conditions: Polycystic Ovary Syndrome; Ovulation Disorder

Treatments: Diagnostic Test: Clusterin level

Study type: Observational

Funder types: Other

Identifiers

NCT06601725

2011-KAEK-25 2021/02-06

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 118 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

118 participants in 4 patient groups

Phenotype A

Description:

Phenotype A was characterized by metabolic syndrome

Treatment:

Diagnostic Test: Clusterin level

Phenotype B

Description:

phenotype B was characterized by the absence of metabolic syndrome

Treatment:

Diagnostic Test: Clusterin level

Phenotype C

Description:

phenotype C was characterized by hyperandrogenism

Treatment:

Diagnostic Test: Clusterin level

Phenotype D

Description:

phenotype D was characterized by the absence of hyperandrogenism

Treatment:

Diagnostic Test: Clusterin level