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

Primary Purpose

Male Infertility

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Coenzyme Q10 200
Coenzyme Q10 400
Sponsored by
University of Sumer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Infertility focused on measuring Male infertility, Coenzyme Q10, Antioxidants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fertility Unit, Babyl

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Coenzyme Q10 200

Coenzyme Q10 400

Arm Description

Coenzyme Q10 200mg/day for 3 months

Coenzyme Q10 400mg/day for 3 months

Outcomes

Primary Outcome Measures

Semen volume (WHO 2010 guidelines)
Semen volume in ml
Sperm concentration in semen (WHO 2010 guidelines)
Sperm concentration in million/ml
Sperm motility in semen (WHO 2010 guidelines)
Sperm motility (%)
Sperm morphology in semen (WHO 2010 guidelines)
Normal sperm morphology (%)
Seminal plasma TAC
Seminal plasma total antioxidant capacity in mmol/ml
Seminal plasma CAT
Seminal plasma catalase in U/ml
Seminal plasma SOD
Superoxide dismutase in U/ml

Secondary Outcome Measures

Full Information

First Posted
February 20, 2019
Last Updated
February 20, 2019
Sponsor
University of Sumer
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1. Study Identification

Unique Protocol Identification Number
NCT03850561
Brief Title
Effect of Two Doses of Coenzyme Q10 on Seminal Fluid and Semen Antioxidant Status
Official Title
The Effect of Two Doses of Coenzyme Q10 on Seminal Fluid Parameters and Antioxidant Status: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sumer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
Male infertility, Coenzyme Q10, Antioxidants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coenzyme Q10 200
Arm Type
Active Comparator
Arm Description
Coenzyme Q10 200mg/day for 3 months
Arm Title
Coenzyme Q10 400
Arm Type
Active Comparator
Arm Description
Coenzyme Q10 400mg/day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10 200
Intervention Description
Coenzyme Q10 200 mg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10 400
Intervention Description
Coenzyme Q10 400 mg/day
Primary Outcome Measure Information:
Title
Semen volume (WHO 2010 guidelines)
Description
Semen volume in ml
Time Frame
3 months
Title
Sperm concentration in semen (WHO 2010 guidelines)
Description
Sperm concentration in million/ml
Time Frame
3 months
Title
Sperm motility in semen (WHO 2010 guidelines)
Description
Sperm motility (%)
Time Frame
3 months
Title
Sperm morphology in semen (WHO 2010 guidelines)
Description
Normal sperm morphology (%)
Time Frame
3 months
Title
Seminal plasma TAC
Description
Seminal plasma total antioxidant capacity in mmol/ml
Time Frame
3 months
Title
Seminal plasma CAT
Description
Seminal plasma catalase in U/ml
Time Frame
3 months
Title
Seminal plasma SOD
Description
Superoxide dismutase in U/ml
Time Frame
3 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male Infertility
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed T Alahmar, MBChB, MSC
Organizational Affiliation
University of Sumer, Iraq
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Unit, Babyl
City
Hilla
ZIP/Postal Code
00964
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Patients data are anonymous and in hold with the principal investigator
Citations:
PubMed Identifier
29984205
Citation
Alahmar AT. The effects of oral antioxidants on the semen of men with idiopathic oligoasthenoteratozoospermia. Clin Exp Reprod Med. 2018 Jun;45(2):57-66. doi: 10.5653/cerm.2018.45.2.57. Epub 2018 Jun 29.
Results Reference
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PubMed Identifier
28771785
Citation
Alshahrani S, Aldossari K, Al-Zahrani J, Gabr AH, Henkel R, Ahmad G. Interpretation of semen analysis using WHO 1999 and WHO 2010 reference values: Abnormal becoming normal. Andrologia. 2018 Mar;50(2). doi: 10.1111/and.12838. Epub 2017 Aug 3.
Results Reference
background
PubMed Identifier
23289958
Citation
Nadjarzadeh A, Shidfar F, Amirjannati N, Vafa MR, Motevalian SA, Gohari MR, Nazeri Kakhki SA, Akhondi MM, Sadeghi MR. Effect of Coenzyme Q10 supplementation on antioxidant enzymes activity and oxidative stress of seminal plasma: a double-blind randomised clinical trial. Andrologia. 2014 Mar;46(2):177-83. doi: 10.1111/and.12062. Epub 2013 Jan 7.
Results Reference
background

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

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