Infertility UnexplainedEarly Phase 1infertilityNCT06342856
Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia
A Early Phase 1 study testing co enzyme Q10 , L- Carnitine in people with Infertility Unexplained and Oligospermia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Infertility Unexplained, Oligospermia
- What is being tested?
- co enzyme Q10 , L- Carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2023to 1 Jul 2024
- Phase
- Early Phase 1
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- of in¬fertility of 1 year or more without the use of contraception
Who cannot join
- o Active genital infections.
- Patients with ejaculatory dysfunction
- Azoospermia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 002
ahmed ma maher, lecturer, 01013340534, drwaleedabdelhamid@gmail.com
About this study
Official title: Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia a Placebo Controlled Clinical Trial
Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia
Read the detailed description
Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia a placebo controlled clinical trial
- Conditions
- Infertility Unexplained, Oligospermia
- Being tested
- co enzyme Q10 , L- Carnitine
- Keywords
- infertility, oligospermia, coenzyme Q1o
- Medical subject headings
- Oligospermia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co enzyme Q10 , L- CarnitineDrug
Patient fulfilling inclusion criteria after obtaining consent will be randomized into four equal groups randomization will be computer based
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | will receive a daily dose of 200 mg of CoQ10 for 3 months Receives: Drug: co enzyme Q10 , L- Carnitine |
| Group 2 | Active comparator | will receive L-carnitine 1 tablet per day orally for 3 months Receives: Drug: co enzyme Q10 , L- Carnitine |
| Group 3 | Active comparator | will receive combination of a daily dose of 200 mg of CoQ10 and 1 tablet of L-carnitine for 3 months Receives: Drug: co enzyme Q10 , L- Carnitine |
| Group 4 | Placebo comparator | will receive a placebo for 3 months Receives: Drug: co enzyme Q10 , L- Carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Semen analysis parameters compared to baseline
Changes in Semen analysis parameters compared to baseline
Measured: 6 months
Secondary outcomes (1)
Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis
Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis
Measured: 6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Jun 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility UnexplainedStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342856
- Sponsor's protocol ID
- idiopathic infertility
- Acronym
- infertility
- Status last verified
- Aug 2023
- First submitted
- 8 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salvio G, Cutini M, Ciarloni A, Giovannini L, Perrone M, Balercia G. Coenzyme Q10 and Male Infertility: A Systematic Review. Antioxidants (Basel). 2021 May 30;10(6):874. doi: 10.3390/antiox10060874.
PubMed 34070761
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia a Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06342856
- Acronym / sponsor ID
- infertility / idiopathic infertility
- Conditions
- Infertility Unexplained, Oligospermia
- Keywords
- infertility, oligospermia, coenzyme Q1o
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 2 Apr 2024 (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.
Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia
Detailed description
Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia a placebo controlled clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: co enzyme Q10 , L- Carnitinewill receive a daily dose of 200 mg of CoQ10 for 3 months |
| Group 2 | Active comparator | Drug: co enzyme Q10 , L- Carnitinewill receive L-carnitine 1 tablet per day orally for 3 months |
| Group 3 | Active comparator | Drug: co enzyme Q10 , L- Carnitinewill receive combination of a daily dose of 200 mg of CoQ10 and 1 tablet of L-carnitine for 3 months |
| Group 4 | Placebo comparator | Drug: co enzyme Q10 , L- Carnitinewill receive a placebo for 3 months |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- of in¬fertility of 1 year or more without the use of contraception
Key exclusion criteria (3 listed)
- o Active genital infections.
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 |
|---|---|---|
| co enzyme Q10 , L- CarnitinePatient fulfilling inclusion criteria after obtaining consent will be randomized into four equal groups randomization will be computer based | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Changes in Semen analysis parameters compared to baseline
Time frame: 6 months
Changes in Semen analysis parameters compared to baseline
1 secondary outcome
Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis
Time frame: 6 moths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Results publication: PubMed 34070761Salvio G, Cutini M, Ciarloni A, Giovannini L, Perrone M, Balercia G. Coenzyme Q10 and Male Infertility: A Systematic Review. Antioxidants (Basel). 2021 May 30;10(6):874. doi: 10.3390/antiox10060874.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing co enzyme Q10 , L- Carnitine in people with Infertility Unexplained and Oligospermia, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact waleed,mo abdelhamid, ass lecturer (01013340534 ext. wa, drwaleedabdelhamid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Semen analysis parameters compared to baseline (time frame: 6 months). 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 NCT06342856, which also lists 1 linked publication.
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 2 Apr 2024.