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Trial Title:
Effect of Coenzyme Q10 Administration on Polycystic Ovary Syndrome
NCT ID:
NCT06659406
Condition:
Polycystic Ovarian Syndrome (PCOS)
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Ubiquinone
Coenzyme Q10
Conditions: Keywords:
PCOS
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Coenzyme Q10
Description:
Coenzyme Q10 will be given once daily, 200mg for the period of 3 months
Arm group label:
CoQ-10 supplementation
Other name:
ubiquinone
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. 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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
biological females would be accepted because this condition effects ovaries that are
present in biological females only
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Madinah Teaching Hospital
Address:
City:
Faisalabad
Zip:
38000
Country:
Pakistan
Contact:
Last name:
Dr Sadia Ijaz, FCPS Hematology
Phone:
+923037869990
Email:
sadia.ijaz@tuf.edu.pk
Contact backup:
Last name:
Dr Sana Akram, FCPS PHYSIOLOGY
Phone:
+923334577182
Email:
sana.akram1986@gmail.com
Contact backup:
Last name:
Hira Zahid, MBBS, Masters in Physiology
Start date:
January 1, 2025
Completion date:
December 2025
Lead sponsor:
Agency:
University of Faisalabad
Agency class:
Other
Collaborator:
Agency:
College of Physicians and Surgeons Pakistan
Agency class:
Other
Source:
University of Faisalabad
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06659406
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668517/
