Male InfertilityNCT03834831
Impact of Coenzyme Q10 and Selenium on Seminal Fluid and Semen Antioxidant Status
A study testing Coenzyme Q10 and Selenium in people with Male Infertility, run by University of Sumer at 1 site in Iraq.
Trial summary
The study was conducted to assess the impact of coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- Coenzyme Q10 and Selenium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jun 2018to 10 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Azoospermia,
- Varicocele,
- Genital tract infection,
- Cryptorchidism,
- Testicular trauma or scrotal surgery,
- Endocrine disorder,
Show all 9Show fewer
- Systemic illness,
- Smoking
- The presence of female factor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Male Infertility
- Being tested
- Coenzyme Q10, Selenium
- Keywords
- Male infertility, Coenzyme Q10, Selenium, Antioxidants
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Dietary supplement
Coenzyme Q10
SeleniumDietary supplement
Selenium
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 | Active comparator | Coenzyme Q10 200mg/day for 3 months Receives: Dietary Supplement: Coenzyme Q10 |
| Selenium | Active comparator | Selenium mcg/day for 3 months Receives: Dietary Supplement: Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen volume (WHO 2010 guidelines)
Semen volume in ml
Measured: 3 months
Sperm concentration in semen (WHO 2010 guidelines)
Sperm concentration in million/ml
Measured: 3 months
Sperm motility in semen (WHO 2010 guidelines)
Sperm motility (%)
Measured: 3 months
Sperm morphology in semen (WHO 2010 guidelines)
Normal sperm morphology (%)
Measured: 3 months
Seminal plasma TAC (Colorimetric assays)
Seminal plasma total antioxidant capacity in mmol/ml
Measured: 3 months
Seminal plasma CAT (Colorimetric assays)
Seminal plasma catalase in U/ml
Measured: 3 months
Seminal plasma SOD (Colorimetric assays)
Superoxide dismutase in U/ml
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Jun 2018
- Primary completion31 Oct 2018
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sumer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ahmed T Alahmar, University of Sumer
- Investigators
- Ahmed T Alahmar, Principal investigator, University of Sumer, Iraq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834831
- Sponsor's protocol ID
- EC/2018/8866
- Status last verified
- Mar 2019
- First submitted
- 6 Feb 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients data are anonymous and in hold with the principal investigator
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.
PubMed 28771785Alahmar 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.
PubMed 29984205
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Coenzyme Q10 and Selenium on Seminal Fluid Parameters and Antioxidant Status in Men With Idiopathic Infertility
- ClinicalTrials.gov ID
- NCT03834831
- Acronym / sponsor ID
- EC/2018/8866
- Conditions
- Male Infertility
- Keywords
- Male infertility, Coenzyme Q10, Selenium, Antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of SumerUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was conducted to assess the impact of coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 | Active comparator | Dietary Supplement: Coenzyme Q10Coenzyme Q10 200mg/day for 3 months |
| Selenium | Active comparator | Dietary Supplement: SeleniumSelenium mcg/day for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- Azoospermia,
- Varicocele,
- Genital tract infection,
- Cryptorchidism,
- Testicular trauma or scrotal surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10Coenzyme Q10 | Dietary supplement | Coenzyme Q10 |
| SeleniumSelenium | Dietary supplement | Selenium |
Primary outcome
Semen volume (WHO 2010 guidelines)
Time frame: 3 months
Semen volume in ml
Sperm concentration in semen (WHO 2010 guidelines)
Time frame: 3 months
Sperm concentration in million/ml
Sperm motility in semen (WHO 2010 guidelines)
Time frame: 3 months
Sperm motility (%)
Sperm morphology in semen (WHO 2010 guidelines)
Time frame: 3 months
Normal sperm morphology (%)
Seminal plasma TAC (Colorimetric assays)
Time frame: 3 months
Seminal plasma total antioxidant capacity in mmol/ml
Seminal plasma CAT (Colorimetric assays)
Time frame: 3 months
Seminal plasma catalase in U/ml
Seminal plasma SOD (Colorimetric assays)
Time frame: 3 months
Superoxide dismutase in U/ml
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Background: PubMed 28771785Alshahrani 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.
- Background: PubMed 29984205Alahmar 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.
- Individual participant dataSharing planned: No. Patients data are anonymous and in hold with the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed T Alahmar principal investigator
University of Sumer, Iraq
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 and Selenium in people with Male Infertility, run by University of Sumer at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen volume (WHO 2010 guidelines) (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03834831, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.