Polycystic Ovarian Syndrome (PCOS)PCOSNCT06659406
Effect of Coenzyme Q10 Administration on Polycystic Ovary Syndrome
A study testing Coenzyme Q10 in people with Polycystic Ovarian Syndrome (PCOS), run by University of Faisalabad at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to determine the effects of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- What is being tested?
- Coenzyme Q10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to Dec 2025
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Married Patients that presented with anovulatory infertility due to PCOS.
- Unmarried Patients that presented with symptoms due to PCOS
- All patients should fulfill Rotterdam criteria for PCOS
Who cannot join
- Male factor infertility ( oligospermia or aspermia)
- Tubal factor infertility (abnormal hysterosalpingography)
- Diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function
- Autoimmune and Inflammatory disorders
- Abnormal serum prolactin level
- Smokers
- Alcoholic beverage use
- Use of anti diabetic, anti-obesity drugs, insulin or vitamin and mineral supplements
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Madinah Teaching Hospital
Faisalabad, Punjab Province, 38000
Dr Sadia Ijaz, FCPS Hematology, +923037869990, sadia.ijaz@tuf.edu.pk
Dr Sana Akram, FCPS PHYSIOLOGY, +923334577182, sana.akram1986@gmail.com
About this study
Official title: The Effect of Coenzyme Q10 Supplementation on Oxidative Stress, Inflammation and Hyperandrogenism in Women with Polycystic Ovary Syndrome
The goal of this clinical trial is to determine the effects of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome. The main questions it aims to answer are:
Does Coenzyme Q10 alter oxidative stress, inflammation and hyperandrogenism in women with Polycystic ovary syndrome.
Participants will take Coenzyme Q10 200mg, once daily for a period of 3 months. The participants will be reassessed after 12 weeks by measuring Malondialdehyde MDA, C-reactive protein CRP, Sex hormone binding globulin SHBG.
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Being tested
- Coenzyme Q10
- Keywords
- 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.
Coenzyme Q10Dietary supplement
Also called ubiquinone
Coenzyme Q10 will be given once daily, 200mg for the period of 3 months
| Study group | Role | What they receive |
|---|---|---|
| CoQ-10 supplementation | Experimental | The experimental arm will consist of fertile females diagnosed with polycystic ovary syndrome aged between 18 to 50 years. Patients with diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function, autoimmune and Inflammatory disorders will be excluded. Receives: Dietary Supplement: Coenzyme Q10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of coenzyme q10 administration on polycystic ovary syndrome
Improvement in levels of oxidative stress , inflammatory and hyperandrogenism biomarkers in women with Polycystic ovary syndrome
Measured: from enrollment to the end of treatment at 12 weeks
The effect of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome
Oxidative stress in PCOS is leads to imbalance in antioxidant and oxidant levels in the body, along with production of reactive oxygen species. Insulin resistance has a key role in the PCOS pathogenesis by promoting oxidative stress and promoting acute and chronic Inflammation. Studies have shown that inflammatory markers are raised in PCOS along with decreased levels of anti-inflammatory biomarkers. Coenzyme Q10 is a natural vitamin, acts as an antioxidant, have shown an constructive impact on inflammatory and endothelial dysfunction biomarkers and also effects androgen levels. Effect of Coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism will be accessed by biomarkers Malondialdehyde MDA, C-reactive protein CRP and Sex hormone binding globulin SHBG. Ideally levels of MDA, CRP would decrease and SHBG levels would increase after Coenzyme Q10 supplementation. This study would measure these three biomarkers before and after the intervention.
Measured: from enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Collaborators
- College of Physicians and Surgeons Pakistan
- Responsible party
- Principal investigator, hira zahid, University of Faisalabad
- Investigators
- Sana Akram, MBBS, FCPS, Study director, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659406
- Sponsor's protocol ID
- Tuf/IRB/275/24
- Acronym
- PCOS
- Status last verified
- Feb 2024
- First submitted
- 14 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patients data will not be shared because it is highly confidential document
Publications
Hu X, Wang W, Su X, Peng H, Tan Z, Li Y, Huang Y. Comparison of nutritional supplements in improving glycolipid metabolism and endocrine function in polycystic ovary syndrome: a systematic review and network meta-analysis. PeerJ. 2023 Nov 13;11:e16410. doi: 10.7717/peerj.16410. eCollection 2023.
PubMed 38025704
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coenzyme Q10 Supplementation on Oxidative Stress, Inflammation and Hyperandrogenism in Women with Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06659406
- Acronym / sponsor ID
- PCOS / Tuf/IRB/275/24
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Keywords
- PCOS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Collaborators
- College of Physicians and Surgeons Pakistan
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Oct 2024 (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 goal of this clinical trial is to determine the effects of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome. The main questions it aims to answer are:
Does Coenzyme Q10 alter oxidative stress, inflammation and hyperandrogenism in women with Polycystic ovary syndrome.
Participants will take Coenzyme Q10 200mg, once daily for a period of 3 months. The participants will be reassessed after 12 weeks by measuring Malondialdehyde MDA, C-reactive protein CRP, Sex hormone binding globulin SHBG.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoQ-10 supplementation | Experimental | Dietary Supplement: Coenzyme Q10The experimental arm will consist of fertile females diagnosed with polycystic ovary syndrome aged between 18 to 50 years. Patients with diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function, autoimmune and Inflammatory disorders will be excluded. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Married Patients that presented with anovulatory infertility due to PCOS.
- Unmarried Patients that presented with symptoms due to PCOS
- All patients should fulfill Rotterdam criteria for PCOS
Key exclusion criteria (8 listed)
- Male factor infertility ( oligospermia or aspermia)
- Tubal factor infertility (abnormal hysterosalpingography)
- Diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function
- Autoimmune and Inflammatory disorders
- Abnormal serum prolactin level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10Also: ubiquinoneCoenzyme Q10 will be given once daily, 200mg for the period of 3 months | Dietary supplement | CoQ-10 supplementation |
Primary outcome
effect of coenzyme q10 administration on polycystic ovary syndrome
Time frame: from enrollment to the end of treatment at 12 weeks
Improvement in levels of oxidative stress , inflammatory and hyperandrogenism biomarkers in women with Polycystic ovary syndrome
The effect of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome
Time frame: from enrollment to the end of treatment at 12 weeks
Oxidative stress in PCOS is leads to imbalance in antioxidant and oxidant levels in the body, along with production of reactive oxygen species. Insulin resistance has a key role in the PCOS pathogenesis by promoting oxidative stress and promoting acute and chronic Inflammation. Studies have shown that inflammatory markers are raised in PCOS along with decreased levels of anti-inflammatory biomarkers. Coenzyme Q10 is a natural vitamin, acts as an antioxidant, have shown an constructive impact on inflammatory and endothelial dysfunction biomarkers and also effects androgen levels. Effect of Coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism will be accessed by biomarkers Malondialdehyde MDA, C-reactive protein CRP and Sex hormone binding globulin SHBG. Ideally levels of MDA, CRP would decrease and SHBG levels would increase after Coenzyme Q10 supplementation. This study would measure these three biomarkers before and after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 38025704Hu X, Wang W, Su X, Peng H, Tan Z, Li Y, Huang Y. Comparison of nutritional supplements in improving glycolipid metabolism and endocrine function in polycystic ovary syndrome: a systematic review and network meta-analysis. PeerJ. 2023 Nov 13;11:e16410. doi: 10.7717/peerj.16410. eCollection 2023.
- Efficacy of coenzyme Q10 supplementation on glucose metabolism, lipid profiles, and biomarkers of inflammation in women with polycystic ovary syndromeLink provided by the sponsor.
- Individual participant dataSharing planned: No. patients data will not be shared because it is highly confidential document
Related trials for Polycystic Ovarian Syndrome (PCOS)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Sana Akram, MBBS, FCPS study director
University of Faisalabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 in people with Polycystic Ovarian Syndrome (PCOS), run by University of Faisalabad at 1 site in Pakistan.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Oct 2024. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hira zahid, MBBS, M.Phil. (+923237624565, drhirazahid@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of coenzyme q10 administration on polycystic ovary syndrome (time frame: from enrollment to the end of treatment at 12 weeks). 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?
On the ClinicalTrials.gov record for NCT06659406, which also lists 1 linked publication.
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 26 Oct 2024.