NCT07849166

Brief Summary

This prospective observational case-control study evaluated serum BRCC36 and telomerase (TE) levels in women with polycystic ovary syndrome (PCOS) and healthy controls. Women aged 18-43 years were included. The study comprised 30 women diagnosed with PCOS according to ESHRE/ASRM criteria and 30 healthy women with regular menstrual cycles. A single 5-mL venous blood sample was collected from each participant. Serum was separated by centrifugation and stored at -80°C until analysis. Serum BRCC36 and telomerase levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits. The study evaluated differences in these biomarkers between women with PCOS and healthy controls and their relationships with clinical and biochemical characteristics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 20, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 24, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

BRCC36TelomeraseDeubiquitinating EnzymesPolycystic Ovary SyndromeBiomarkers

Outcome Measures

Primary Outcomes (2)

  • Serum BRCC36 Level

    Serum BRCC36 levels measured using a commercially available human ELISA kit and compared between the PCOS and healthy control groups.

    At study enrollment (single blood collection)

  • Serum Telomerase Level

    Serum telomerase (TE) levels measured using a commercially available human ELISA kit and compared between the PCOS and healthy control groups.

    At study enrollment (single blood collection)

Study Arms (2)

PCOS Group

Women aged 18-43 years diagnosed with polycystic ovary syndrome according to ESHRE/ASRM criteria (n=30).

Healthy Control Group

Healthy women aged 18-43 years with regular menstrual cycles and without clinical or ultrasonographic features of PCOS (n=30).

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women aged 18-43 years attending Sivas Cumhuriyet University Faculty of Medicine Hospital were included. The study population consisted of 30 women diagnosed with PCOS according to ESHRE/ASRM criteria and 30 healthy women with regular menstrual cycles who served as controls. All participants were non-obese (BMI \<30 kg/m²) and provided written informed consent.

You may qualify if:

  • Women aged 18-43 years.
  • PCOS group: diagnosis of PCOS according to ESHRE/ASRM criteria, based on the presence of at least two of the following: oligo- and/or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology.
  • Control group: healthy women with regular menstrual cycles (21-35 days), modified Ferriman-Gallwey score \<8, and no unilateral or bilateral polycystic ovarian morphology on pelvic ultrasonography.
  • BMI \<30 kg/m².
  • No oral contraceptive use during the study period or within the previous 6 months.
  • Written informed consent.

You may not qualify if:

  • Thyroid dysfunction, prolactinoma, Cushing disease, or late-onset congenital adrenal hyperplasia.
  • Diabetes mellitus, hypertension, dyslipidemia, coronary artery disease, or renal or hepatic dysfunction.
  • Additional gynecological disease.
  • Use of medications affecting sex hormone or carbohydrate metabolism.
  • Inadequate or unsuitable blood/serum sample for laboratory analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Sivas, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples collected from venous blood and stored at -80°C for BRCC36 and telomerase (TE) measurements by ELISA.

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Dilara Ülger Özbek, PhD

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

September 24, 2026

First Posted

September 30, 2026

Study Start

February 20, 2024

Primary Completion

February 20, 2025

Study Completion

May 1, 2026

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

maybe after de article submission i will plan to share.

Locations