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Effect of Two Doses of Coenzyme Q10 on Seminal Fluid and Semen Antioxidant Status

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03850561
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Ahmed T Alahmar, University of Sumer

Brief Summary:
The study was conducted to assess the impact of two doses of coenzyme Q10 on seminal fluid parameters and antioxidant status in infertile men.

Condition or disease Intervention/treatment Phase
Male Infertility Dietary Supplement: Coenzyme Q10 200 Dietary Supplement: Coenzyme Q10 400 Not Applicable

Detailed Description:
The aim of this study was to assess the impact of two doses of coenzyme Q10 on seminal fluid parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Two Doses of Coenzyme Q10 on Seminal Fluid Parameters and Antioxidant Status: A Randomised Controlled Trial
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : January 25, 2019


Arm Intervention/treatment
Active Comparator: Coenzyme Q10 200
Coenzyme Q10 200mg/day for 3 months
Dietary Supplement: Coenzyme Q10 200
Coenzyme Q10 200 mg/day

Active Comparator: Coenzyme Q10 400
Coenzyme Q10 400mg/day for 3 months
Dietary Supplement: Coenzyme Q10 400
Coenzyme Q10 400 mg/day




Primary Outcome Measures :
  1. Semen volume (WHO 2010 guidelines) [ Time Frame: 3 months ]
    Semen volume in ml

  2. Sperm concentration in semen (WHO 2010 guidelines) [ Time Frame: 3 months ]
    Sperm concentration in million/ml

  3. Sperm motility in semen (WHO 2010 guidelines) [ Time Frame: 3 months ]
    Sperm motility (%)

  4. Sperm morphology in semen (WHO 2010 guidelines) [ Time Frame: 3 months ]
    Normal sperm morphology (%)

  5. Seminal plasma TAC [ Time Frame: 3 months ]
    Seminal plasma total antioxidant capacity in mmol/ml

  6. Seminal plasma CAT [ Time Frame: 3 months ]
    Seminal plasma catalase in U/ml

  7. Seminal plasma SOD [ Time Frame: 3 months ]
    Superoxide dismutase in U/ml



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male Infertility
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of infertility of at least 12 months despite regular unprotected intercourse.

Oligoasthenoteratospermia was diagnosed by semen analysis showing abnormal sperm concentration (<15 million/ml), progressive motility (<32%), total motility (<40%) and morphology (<30% WHO criteria) as defined by WHO manual for semen analysis 2010

Exclusion Criteria:

  • Azoospermia,
  • Varicocele,
  • Genital tract infection,
  • Cryptorchidism,
  • Testicular trauma or scrotal surgery,
  • Endocrine disorder,
  • Systemic illness,
  • Smoking
  • The presence of female factor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850561


Locations
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Iraq
Fertility Unit, Babyl
Hilla, Iraq, 00964
Sponsors and Collaborators
University of Sumer
Investigators
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Principal Investigator: Ahmed T Alahmar, MBChB, MSC University of Sumer, Iraq
Publications:
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Responsible Party: Dr. Ahmed T Alahmar, Principal Investigator, University of Sumer
ClinicalTrials.gov Identifier: NCT03850561    
Other Study ID Numbers: EC/2018/8878
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patients data are anonymous and in hold with the principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Ahmed T Alahmar, University of Sumer:
Male infertility
Coenzyme Q10
Antioxidants
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Ubiquinone
Coenzyme Q10
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamins