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

February 20, 2019 updated by: Dr. Ahmed T Alahmar, University of Sumer

The Effect of Two Doses of Coenzyme Q10 on Seminal Fluid Parameters and Antioxidant Status: A Randomised Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Hilla, Iraq, 00964
        • Fertility Unit, Babyl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semen volume (WHO 2010 guidelines)
Time Frame: 3 months
Semen volume in ml
3 months
Sperm concentration in semen (WHO 2010 guidelines)
Time Frame: 3 months
Sperm concentration in million/ml
3 months
Sperm motility in semen (WHO 2010 guidelines)
Time Frame: 3 months
Sperm motility (%)
3 months
Sperm morphology in semen (WHO 2010 guidelines)
Time Frame: 3 months
Normal sperm morphology (%)
3 months
Seminal plasma TAC
Time Frame: 3 months
Seminal plasma total antioxidant capacity in mmol/ml
3 months
Seminal plasma CAT
Time Frame: 3 months
Seminal plasma catalase in U/ml
3 months
Seminal plasma SOD
Time Frame: 3 months
Superoxide dismutase in U/ml
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sumer

Investigators

  • Principal Investigator: Ahmed T Alahmar, MBChB, MSC, University of Sumer, Iraq

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

January 25, 2019

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2018/8878

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Patients data are anonymous and in hold with the principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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