Clusterin Level and Polycystic Ovary Syndrome | NCT06601725

Studies
Clusterin Level and Polycystic Ovary Syndrome

NCT06601725

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

118Actual

Phase

Not provided

Conditions

Polycystic Ovary Syndrome
Ovulation Disorder

Interventions

Clusterin level

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Nov 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Sep 16, 2024

First Submission Date that Met QC Criteria

Sep 16, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nefise Nazlı YENIGUL, Ph.D. Assistant Professor Department of Obstetrics and Gynecology, Sanliurfa Mehmet Akif Inan Education and Research HospitalPrincipal Investigator

Lead Sponsor

Sanliurfa Mehmet Akif Inan Education and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

7 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Phenotype A	Phenotype A was characterized by metabolic syndrome	Diagnostic Test: Clusterin level
Phenotype B	phenotype B was characterized by the absence of metabolic syndrome	Diagnostic Test: Clusterin level
Phenotype C	phenotype C was characterized by hyperandrogenism	Diagnostic Test: Clusterin level
Phenotype D	phenotype D was characterized by the absence of hyperandrogenism	Diagnostic Test: Clusterin level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clusterin level	Diagnostic Test	Clusterin plays a role in inflammation and oxidative stress processes such as metabolic syndrome, insulin resistance, and atherosclerosis	Phenotype A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CLusterin level	primary outcome is the measurement of blood Clusterin (Apolipoprotein J) levels in healthy women with and without PCOS	7 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

118 women who were diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria, as well as 62 healthy women of the same age without any cardiovascular risk factors. Patients diagnosed with PCOS were classified into four phenotypes: A, B, C, and D. Phenotype A was characterized by metabolic syndrome, phenotype B was characterized by the absence of metabolic syndrome, phenotype C was characterized by hyperandrogenism, and phenotype D was characterized by the absence of hyperandrogenism.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nefise Nazlı Yenigül		Bursa		16110	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Blood samples were collected after at least 12 hours of fasting, 5 mL from the antecubital vein, with the patient in a sitting position using a vacutainer. The samples were placed in a gel tube (biochemistry tube) and centrifuged at 4000 rpm for 5 minutes. Storage conditions were ensured. The samples were stored in a cabinet at -80 degrees Celsius in the genetics laboratory. Clusterin levels were measured using the BT LAB Human Clusterin (CLU) ELISA kit, with min-max values of 0.5-300 ng/ml.