- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03834831
Impact of Coenzyme Q10 and Selenium on Seminal Fluid and Semen Antioxidant Status
March 12, 2019 updated by: Dr. Ahmed T Alahmar, University of Sumer
Impact of Coenzyme Q10 and Selenium on Seminal Fluid Parameters and Antioxidant Status in Men With Idiopathic Infertility
The study was conducted to assess the impact of coenzyme Q10 and selenium 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 coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.
Study Type
Interventional
Enrollment (Actual)
70
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
-
-
-
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
18 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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Coenzyme Q10
Coenzyme Q10 200mg/day for 3 months
|
Coenzyme Q10
|
ACTIVE_COMPARATOR: Selenium
Selenium mcg/day for 3 months
|
Selenium
|
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 (Colorimetric assays)
Time Frame: 3 months
|
Seminal plasma total antioxidant capacity in mmol/ml
|
3 months
|
Seminal plasma CAT (Colorimetric assays)
Time Frame: 3 months
|
Seminal plasma catalase in U/ml
|
3 months
|
Seminal plasma SOD (Colorimetric assays)
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
Investigators
- Principal Investigator: Ahmed T Alahmar, 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
- 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.
- 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.
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)
October 31, 2018
Study Completion (ACTUAL)
January 10, 2019
Study Registration Dates
First Submitted
February 6, 2019
First Submitted That Met QC Criteria
February 6, 2019
First Posted (ACTUAL)
February 8, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 14, 2019
Last Update Submitted That Met QC Criteria
March 12, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/2018/8866
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
product manufactured in and exported from the U.S.
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.
Clinical Trials on Male Infertility
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMale Infertility, AzoospermiaUnited States
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Reproductive Medicine Associates of New JerseyTerminated
-
Jinling Hospital, ChinaRecruitingMale Infertility Due to HypospermatogenesisChina
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
Hillel Yaffe Medical CenterUnknownMale Infertility With Severe Oligo-terato-asteno-spermiaIsrael
-
Universitair Ziekenhuis BrusselRecruitingMale InfertilityBelgium
-
Istituto Clinico HumanitasRecruiting
Clinical Trials on Coenzyme Q10
-
University of SumerCompletedMale InfertilityIraq
-
University of ShizuokaCompletedHemodialysis | Chronic Renal FailureJapan
-
Central Hospital, Nancy, FranceCompletedCyclic Vomiting SyndromeFrance
-
Columbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)CompletedAmyotrophic Lateral Sclerosis | Lou Gehrig's DiseaseUnited States
-
Hadassah Medical OrganizationUnknown
-
Peter HumaidanCompleted
-
Johns Hopkins UniversityNational Institute of Neurological Disorders and Stroke (NINDS)CompletedHuntington's DiseaseUnited States
-
Technische Universität DresdenDeutsche Parkinson-Vereinigung e.V.; MSE Pharmazeutika GmbH, Bad HomburgCompleted
-
Mclean HospitalNational Alliance for Research on Schizophrenia and DepressionCompleted
-
National University Hospital, SingaporeCompletedParkinson DiseaseSingapore