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Impact of Coenzyme Q10 and Selenium on Seminal Fluid and Semen Antioxidant Status

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ClinicalTrials.gov Identifier: NCT03834831
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Ahmed T Alahmar, University of Sumer

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

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

Detailed Description:
The aim of this study was to assess the impact of coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 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: Impact of Coenzyme Q10 and Selenium on Seminal Fluid Parameters and Antioxidant Status in Men With Idiopathic Infertility
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : January 10, 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Coenzyme Q10
Coenzyme Q10 200mg/day for 3 months
 Dietary Supplement: Coenzyme Q10
Coenzyme Q10
Active Comparator: Selenium
Selenium mcg/day for 3 months
 Dietary Supplement: Selenium
Selenium


Outcome Measures
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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 (Colorimetric assays) [ Time Frame: 3 months ]
    Seminal plasma total antioxidant capacity in mmol/ml

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

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


Eligibility Criteria
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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
Contacts and Locations
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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): NCT03834831


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 University of Sumer, Iraq
More Information
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Publications:

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Responsible Party: Dr. Ahmed T Alahmar, Principal Investigator, University of Sumer
ClinicalTrials.gov Identifier: NCT03834831    
Other Study ID Numbers: EC/2018/8866
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr. Ahmed T Alahmar, University of Sumer:
Male infertility
Coenzyme Q10
Selenium
Antioxidants
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Genital Diseases
Urogenital Diseases
Genital Diseases, Male
Male Urogenital Diseases
Selenium
Ubiquinone
 Coenzyme Q10
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Vitamins