Effect of Coenzyme Q10 Administration on Polycystic Ovary Syndrome

Not Applicable

Not yet recruiting

• Conditions: Polycystic Ovarian Syndrome (PCOS)

• Registration Number: NCT06659406
• Lead Sponsor: University of Faisalabad

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-23
• Last Update Submitted: 2024-10-23
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Study Start: 2025-01-01
• Primary Completion: 2025-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
effect of coenzyme q10 administration on polycystic ovary syndrome	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	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.

Trial Locations

Locations (1)

Madinah Teaching Hospital; 🇵🇰 Faisalabad, Punjab, Pakistan