Polycystic Ovarian Syndrome (PCOS)NCT06826625
Oxidative Stress in Polycystic Ovary Syndrome
An observational study of Polycystic Ovarian Syndrome (PCOS) and Oxidative Stress, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to determine changes in hematological and biochemical parameters and specific oxidative stress markers in patients with PCOS. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS), Oxidative Stress
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2021to 1 Feb 2025
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Woman with and without polycystic ovary syndrome
Who may be able to join
- The PCOS group included patients with oligomenorrhea (menstrual period intervals of more than 35 days), clinical signs of hyperandrogenism (acne or hirsutism), biochemical signs of hyperandrogenism (with total testosterone of 100 ng/dL and above and patients with dehydroepiandrosterone sulfate of 400 g/dl and above), an LH/FSH ratio of over 3 on the second day of the menstrual period, a body mass index of 25 and above, and polycystic ovaries detected in suprapubic ultrasonography.
Who cannot join
- Pregnant individuals, individuals with diabetes mellitus, metabolic syndrome, adrenal pathology, pelvic mass, and malignancy were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Training and Research Hospital Gynecology and Obstetrics Department
Antalya
About this study
Official title: Elucidation of the Oxidative Mechanism Effective in Polycystic Ovary Syndrome: a Randomized Controlled Clinical Study
The aim of the study was to determine changes in hematological and biochemical parameters and specific oxidative stress markers in patients with PCOS.
- 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 |
|---|---|---|
| polycystic ovary syndrome | Woman with PCOS | |
| control | Women without PCOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress markers
TAS, TOS, OSI, PON, ARES, total thiol, native thiol, disulfide (-S-S-), reduced thiol, oxidized thiol, and IMA
Measured: From January 2021 to December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start2 Jan 2021
- Primary completion30 Dec 2021
- Study completion1 Feb 2025
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
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Basri Savas, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826625
- Sponsor's protocol ID
- 2020/23-11
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidation of the Oxidative Mechanism Effective in Polycystic Ovary Syndrome: a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06826625
- Acronym / sponsor ID
- 2020/23-11
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 14 Feb 2025 (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.
The aim of the study was to determine changes in hematological and biochemical parameters and specific oxidative stress markers in patients with PCOS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polycystic ovary syndrome | – | –Woman with PCOS |
| control | – | –Women without PCOS |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Woman with and without polycystic ovary syndrome
Key inclusion criteria (1 listed)
- The PCOS group included patients with oligomenorrhea (menstrual period intervals of more than 35 days), clinical signs of hyperandrogenism (acne or hirsutism), biochemical signs of hyperandrogenism (with total testosterone of 100 ng/dL and above and patients with dehydroepiandrosterone sulfate of 400 g/dl and above), an LH/FSH ratio of over 3 on the second day of the menstrual period, a body mass index of 25 and above, and polycystic ovaries detected in suprapubic ultrasonography.
Key exclusion criteria (1 listed)
- Pregnant individuals, individuals with diabetes mellitus, metabolic syndrome, adrenal pathology, pelvic mass, and malignancy were not included in the study.
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
Oxidative stress markers
Time frame: From January 2021 to December 2021
TAS, TOS, OSI, PON, ARES, total thiol, native thiol, disulfide (-S-S-), reduced thiol, oxidized thiol, and IMA
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 14 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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) and Oxidative Stress, run by Mardin Artuklu 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 1 inclusion and 1 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 14 Feb 2025. 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?
Oxidative stress markers (time frame: From January 2021 to December 2021). 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 14 Feb 2025.