Effect of Coenzyme Q10 Administration on Polycystic Ovary Syndrome (PCOS)

October 23, 2024 updated by: hira zahid, University of Faisalabad

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000
        • Madinah Teaching Hospital
        • Contact:
        • Contact:
        • Contact:
          • Hira Zahid, MBBS, Masters in Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CoQ-10 supplementation
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.
Dietary supplement: Coenzyme Q10
Coenzyme Q10 will be given once daily, 200mg for the period of 3 months
Other Names:
  • ubiquinone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
from enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Faisalabad

Collaborators

College of Physicians and Surgeons Pakistan

Investigators

  • Study Director: Sana Akram, MBBS, FCPS, University of Faisalabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tuf/IRB/275/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

patients data will not be shared because it is highly confidential document

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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