NCT03850561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

February 20, 2019

Last Update Submit

February 20, 2019

Conditions

Male Infertility

Keywords

Male infertilityCoenzyme Q10Antioxidants

Outcome Measures

Primary Outcomes (7)

  • Semen volume (WHO 2010 guidelines)

    Semen volume in ml

    3 months

  • Sperm concentration in semen (WHO 2010 guidelines)

    Sperm concentration in million/ml

    3 months

  • Sperm motility in semen (WHO 2010 guidelines)

    Sperm motility (%)

    3 months

  • Sperm morphology in semen (WHO 2010 guidelines)

    Normal sperm morphology (%)

    3 months

  • Seminal plasma TAC

    Seminal plasma total antioxidant capacity in mmol/ml

    3 months

  • Seminal plasma CAT

    Seminal plasma catalase in U/ml

    3 months

  • Seminal plasma SOD

    Superoxide dismutase in U/ml

    3 months

Study Arms (2)

Coenzyme Q10 200

ACTIVE COMPARATOR

Coenzyme Q10 200mg/day for 3 months

Dietary Supplement: Coenzyme Q10 200

Coenzyme Q10 400

ACTIVE COMPARATOR

Coenzyme Q10 400mg/day for 3 months

Dietary Supplement: Coenzyme Q10 400

Interventions

Coenzyme Q10 200DIETARY_SUPPLEMENT

Coenzyme Q10 200 mg/day

Coenzyme Q10 200
Coenzyme Q10 400DIETARY_SUPPLEMENT

Coenzyme Q10 400 mg/day

Coenzyme Q10 400

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale Infertility
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Unit, Babyl

Hillah, 00964, Iraq

Location

Related Publications (3)

  • 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.

    PMID: 29984205BACKGROUND

  • 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.

    PMID: 28771785BACKGROUND

  • 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.

    PMID: 23289958BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Ahmed T Alahmar, MBChB, MSC

    University of Sumer, Iraq

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 22, 2019

Study Start

June 1, 2018

Primary Completion

November 20, 2018

Study Completion

January 25, 2019

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Patients data are anonymous and in hold with the principal investigator

Locations

IR(1)