Polycystic Ovarian Syndrome (PCOS)NCT07849166
BRCC36 and Telomerase Levels in Women With Polycystic Ovary Syndrome
An observational study of Polycystic Ovarian Syndrome (PCOS), run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2024to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Serum BRCC36 and Telomerase Levels in Women With Polycystic Ovary Syndrome
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.
Read the detailed description
This prospective observational case-control study included women aged 18-43 years with polycystic ovary syndrome (PCOS) and healthy controls. PCOS was diagnosed according to ESHRE/ASRM criteria based on the presence of at least two of the following features: oligo- and/or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology on ultrasonography.
Participants underwent clinical and anthropometric evaluation, including body mass index and modified Ferriman-Gallwey scoring. Available biochemical and hormonal parameters obtained during routine clinical evaluation were also recorded.
For the study-specific biomarker analyses, a single 5-mL venous blood sample was collected from each participant into a serum separator tube. Samples were centrifuged at 3000 rpm for 10 minutes, and the separated sera were stored at -80°C until analysis. Serum BRCC36, a deubiquitinating enzyme-related biomarker, and telomerase (TE) levels were measured using commercially available human ELISA kits.
The primary objective was to compare serum BRCC36 and telomerase levels between women with PCOS and healthy controls. Associations between these biomarkers and clinical and biochemical characteristics were also evaluated.
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- BRCC36, Telomerase, Deubiquitinating Enzymes, Polycystic Ovary Syndrome, Biomarkers
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum BRCC36 Level
Serum BRCC36 levels measured using a commercially available human ELISA kit and compared between the PCOS and healthy control groups.
Measured: 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.
Measured: At study enrollment (single blood collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start20 Feb 2024
- Primary completion20 Feb 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Ulger Ozbek, Cumhuriyet University
- Investigators
- Dilara Ülger Özbek, PhD, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849166
- Sponsor's protocol ID
- PCOS-Dubs-TE
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: maybe after de article submission i will plan to share.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum BRCC36 and Telomerase Levels in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07849166
- Acronym / sponsor ID
- PCOS-Dubs-TE
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- BRCC36, Telomerase, Deubiquitinating Enzymes, Polycystic Ovary Syndrome, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective observational case-control study included women aged 18-43 years with polycystic ovary syndrome (PCOS) and healthy controls. PCOS was diagnosed according to ESHRE/ASRM criteria based on the presence of at least two of the following features: oligo- and/or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology on ultrasonography.
Participants underwent clinical and anthropometric evaluation, including body mass index and modified Ferriman-Gallwey scoring. Available biochemical and hormonal parameters obtained during routine clinical evaluation were also recorded.
For the study-specific biomarker analyses, a single 5-mL venous blood sample was collected from each participant into a serum separator tube. Samples were centrifuged at 3000 rpm for 10 minutes, and the separated sera were stored at -80°C until analysis. Serum BRCC36, a deubiquitinating enzyme-related biomarker, and telomerase (TE) levels were measured using commercially available human ELISA kits.
The primary objective was to compare serum BRCC36 and telomerase levels between women with PCOS and healthy controls. Associations between these biomarkers and clinical and biochemical characteristics were also evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum BRCC36 Level
Time frame: At study enrollment (single blood collection)
Serum BRCC36 levels measured using a commercially available human ELISA kit and compared between the PCOS and healthy control groups.
Serum Telomerase Level
Time frame: At study enrollment (single blood collection)
Serum telomerase (TE) levels measured using a commercially available human ELISA kit and compared between the PCOS and healthy control groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. maybe after de article submission i will plan to share.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilara Ülger Özbek, PhD principal investigator
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovarian Syndrome (PCOS), run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum BRCC36 Level (time frame: At study enrollment (single blood collection)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.