AntioxidantsPhase 4NCT03464656
Oxidative Stress In Semen And Male Infertility
A Phase 4 study testing Fairhaven Pro for men, Semen analysis and Sperm DNA fragmentation in people with Antioxidants and Infertility, Male, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Antioxidants, Infertility, Male, Semen Quality
- What is being tested?
- Fairhaven Pro for men, Semen analysis and Sperm DNA fragmentation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteQatar
- Study dates
- 1 Jan 2018to 1 Dec 2018
- Phase
- Phase 4
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Abnormal sperm parameters defined as having at least two out of the following three criteria:
- Sperm Concentration > 1 and ≤ 15 million per ml
- Sperm total Motility ≤ 40%
- Sperm Morphology by Strict Criteria; normal forms ≤ 4.0%
- Absence of infection in semen (pus cells < 1 X 106/ml)
- No history of taking any therapy for their infertility including OTC treatment and vitamin supplementation
- No history of obstructive azoospermia
- No history of testicular cancer
Who cannot join
- Semen volume ≤ 1.5 mL
- Hydrocele, clinical varicocele (grade 2 and higher), orchitis, epididymitis, Cryptorchidism, irradiation or subjects that received chemotherapy treatment
- Clinically meaningful endocrinopathy defined as an endocrinopathy which requires endocrine medications (e.g. Diabetes, Thyroid disease, Pituitary diseases, Adrenal diseases, etc.) or measurement of the following hormonal values:
- Testosterone < 10.4 nmol/L
- LH <1 or > 9 IU/L and or FSH <1 or >19 IU/mL
- Elevated prolactin >407 mIU/L
Show all 17Show fewer
- Elevated TSH > 4.5 U/mL
- Elevated Estrogen> 275 pmol/L
- Leukocytospermia: WBC count of > 1 X 106/ ml
- Known HIV infection
- Use of antioxidant agents or vitamins within 8 weeks prior to inclusion into the study
- Consumption of more than 1 unit of alcohol daily*
- Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.
- History of current use of illegal or "recreational" drugs
- History of malignancy not curatively treated at least 5 years before screening visit with exception of basal cell carcinoma in situ which may have been curatively treated within 1 year
- Participation in another clinical trial within 30 days or 7 half-lives of the prior test product, whichever is longer
- Any condition which, in the opinion of the investigator, might put the subject at risk by participation in this study
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha
Mohamed Arafa, MD, +97455198169, myamani@hamad.qa
Haitham Elbardisi, MD, +97455892698, helbardisi@hamad.qa
About this study
The proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. They will be asked to provide a sample of semen for routine semen analysis and advanced semen tests including sperm DNA fragmentation and sORP before starting with antioxidant therapy and after 3-month treatment with antioxidants.
After completing the data analysis, we intend to publish the study in high impact perr reviewed journals and present it in international conferences.
Read the detailed description
The proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Several studies have been conducted to evaluate the effect of many antioxidant regimens on male infertility. A randomized double-blind, placebo-controlled trial investigated a combined antioxidant regimen, including vitamin C, using Menevit (lycopene 6mg, vitamin E 400IU, vitamin C 100mg, zinc 25mg, selenium 26 mcg, folate 0.5mg, garlic 1g) in couples undergoing intracytoplasmic sperm injection. The authors reported a significant improvement in viable pregnancy rate in the treatment group, where 38.5% of transferred embryos resulted in a viable fetus compared to 16% in the placebo group (Tremellen K, 2007). Suleiman et al. studied 300 mg of daily vitamin E in a placebo-controlled study revealing significant improvement in sperm motility and reduction of oxidative stress measures in the treatment group. Moreover, they reported a 21% spontaneous pregnancy rate in the treatment group compared to 0% in the placebo group (Suleiman SA, 1996).
Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. They will be asked to provide a sample of semen for routine semen analysis and advanced semen tests including sperm DNA fragmentation and sORP before starting with antioxidant therapy and after 3-month treatment with antioxidants. No other procedures will be done for research purposes. All other investigations or treatments will be given according to the standard of care. Routinely patients presenting to the male infertility unit at HMC seeking evaluation and treatment for delayed conception will be assessed with a history and physical examination, investigated with semen and endocrine studies and be placed on an antioxidant regimen comprised of vitamins C and E, L-Carnitine and pentoxyfylline. Further management will be individualized and planned according to each patient's condition.
- Conditions
- Antioxidants, Infertility, Male, Semen Quality
- Being tested
- Fairhaven Pro for men, Semen analysis, Sperm DNA fragmentation, Static Oxidation reduction potential in semen
- Keywords
- semen, male infertility, semen quality, sperm DNA fragmentation, oxidation reduction potential
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fairhaven Pro for menDrug
Also called Antioxidant
Fairhaven Pro for men
The antioxidant formula (Fairhaven Health) contains:
- B12 (1000 mcg)
- Zinc (30 mg)
- Selenium (140 mcg)
- Arginine (350 mg)
- L-carnitine tartrate (2000 mg) , providing 1,340 mg of L-carnitine
- CoQ10 (200 mg)
- Vitamin C (120 mg) and Vitamin E (200 IU)
Semen analysisDiagnostic test
Also called Semen test
Full semen analysis according to WHO semen laboratory manual 5th edition will be done pre and 3 months post-treatment.
After complete liquefaction, each sample was evaluated for both macroscopic parameters such as color, pH, ejaculate volume, age of the sample and viscosity. An aliquot of the sample was examined for sperm concentration, total sperm count, total and progressive motility and sperm morphology using the WHO fifth edition guidelines (WHO, 2010). Semen analysis was done manually using a hemocytometer. Sperm motility was assessed and categorized as progressive or non-progressive. Morphology was assessed by a single experienced technician using the Diff-Quik staining protocol. Kruger's strict criteria were used for morphology assessment with 4% normal morphology as a cut-off (WHO, 2010).
Sperm DNA fragmentationDiagnostic test
Also called SDF
Sperm DNA fragmentation was evaluated using the Halosperm kit from Halotech DNA, S.L. (Madrid, Spain) as per manufacturer instructions. The method is based on the sperm chromatin dispersion test (Fernández et al., 2003). A minimum of 500 spermatozoa were scored and reported as percentage of sperm with spermatozoa with fragmented DNA. Normal value is measure at a cut-off value of more than 30%
Static Oxidation reduction potential in semenDiagnostic test
Also called sORP, Oxidative stress
Oxidative stress was assessed by measuring the static oxidation-reduction potential (sORP) of neat liquefied semen samples using the MiOXSYSTM System (Aytu Bioscience, Inc., Englewood, USA). This is a galvanostatic measure of the electron transfer from reductants (antioxidants) to oxidants under a steady low voltage reducing current. Thus, providing an aggregate measure of all current oxidant activity and antioxidant activity in a sample. Higher sORP values (millivolts, mV) indicate a higher oxidant activity relative to the antioxidant activity and therefore greater state of oxidative stress.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study.
Interventions:
* Patients will be given Fairhaven Pro for Men as antioxidant in a dose of 3 tablets twice daily for 3 months.
* Full assessment of fertility will be done. Receives: Drug: Fairhaven Pro for men; Diagnostic Test: Semen analysis; Diagnostic Test: Sperm DNA fragmentation; Diagnostic Test: Static Oxidation reduction potential in semen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of antioxidant therapy on sperm motility in infertile men,
Measured by mean change in sperm motility pre- and post-treatment with antioxidants.
Measured: 1 year
Evaluate the effect of antioxidant therapy on sperm morphology in infertile men
Measured by the mean change in sperm morphology pre- and post-treatment with antioxidants
Measured: 1 year
Evaluate the effect of antioxidant therapy on sperm count in infertile men
Measured by mean change in sperm count pre- and post-treatment with antioxidants.
Measured: 1 year
Secondary outcomes (2)
Evaluate the effect of antioxidant therapy on sperm DNA fragmentation in infertile men
Difference in mean change in sperm DNA fragmentation pre and post-treatment
Measured: 1 year
Evaluate the effect of antioxidant therapy on oxidative stress in infertile men
Measure difference in mean change in seminal oxidation reduction potential in infertile men pre- and post-treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Jan 2018
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntioxidantsStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, prospective, comparative study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fairhaven Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464656
- Sponsor's protocol ID
- 16351/16
- Status last verified
- Jan 2018
- First submitted
- 26 Feb 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress In Semen And Male Infertility
- ClinicalTrials.gov ID
- NCT03464656
- Acronym / sponsor ID
- 16351/16
- Conditions
- Antioxidants, Infertility, Male, Semen Quality
- Keywords
- semen, male infertility, semen quality, sperm DNA fragmentation, oxidation reduction potential
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Fairhaven Health
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 14 Mar 2018 (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 proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. They will be asked to provide a sample of semen for routine semen analysis and advanced semen tests including sperm DNA fragmentation and sORP before starting with antioxidant therapy and after 3-month treatment with antioxidants.
After completing the data analysis, we intend to publish the study in high impact perr reviewed journals and present it in international conferences.
Detailed description
The proposed research aims to study the effects of antioxidant therapy, commonly used in male infertility treatment, on semen analysis. Several studies have been conducted to evaluate the effect of many antioxidant regimens on male infertility. A randomized double-blind, placebo-controlled trial investigated a combined antioxidant regimen, including vitamin C, using Menevit (lycopene 6mg, vitamin E 400IU, vitamin C 100mg, zinc 25mg, selenium 26 mcg, folate 0.5mg, garlic 1g) in couples undergoing intracytoplasmic sperm injection. The authors reported a significant improvement in viable pregnancy rate in the treatment group, where 38.5% of transferred embryos resulted in a viable fetus compared to 16% in the placebo group (Tremellen K, 2007). Suleiman et al. studied 300 mg of daily vitamin E in a placebo-controlled study revealing significant improvement in sperm motility and reduction of oxidative stress measures in the treatment group. Moreover, they reported a 21% spontaneous pregnancy rate in the treatment group compared to 0% in the placebo group (Suleiman SA, 1996).
Patients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. They will be asked to provide a sample of semen for routine semen analysis and advanced semen tests including sperm DNA fragmentation and sORP before starting with antioxidant therapy and after 3-month treatment with antioxidants. No other procedures will be done for research purposes. All other investigations or treatments will be given according to the standard of care. Routinely patients presenting to the male infertility unit at HMC seeking evaluation and treatment for delayed conception will be assessed with a history and physical examination, investigated with semen and endocrine studies and be placed on an antioxidant regimen comprised of vitamins C and E, L-Carnitine and pentoxyfylline. Further management will be individualized and planned according to each patient's condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, prospective, comparative study
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: Fairhaven Pro for men, Diagnostic Test: Semen analysis, Diagnostic Test: Sperm DNA fragmentation, Diagnostic Test: Static Oxidation reduction potential in semenPatients presenting with male infertility, who are found to have abnormal semen analysis shall be recruited to this study. Interventions: * Patients will be given Fairhaven Pro for Men as antioxidant in a dose of 3 tablets twice daily for 3 months. * Full assessment of fertility will be done. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Abnormal sperm parameters defined as having at least two out of the following three criteria:
- Sperm Concentration > 1 and ≤ 15 million per ml
- Sperm total Motility ≤ 40%
- Sperm Morphology by Strict Criteria; normal forms ≤ 4.0%
- Absence of infection in semen (pus cells < 1 X 106/ml)
Key exclusion criteria (17 listed)
- Semen volume ≤ 1.5 mL
- Hydrocele, clinical varicocele (grade 2 and higher), orchitis, epididymitis, Cryptorchidism, irradiation or subjects that received chemotherapy treatment
- Clinically meaningful endocrinopathy defined as an endocrinopathy which requires endocrine medications (e.g. Diabetes, Thyroid disease, Pituitary diseases, Adrenal diseases, etc.) or measurement of the following hormonal values:
- Leukocytospermia: WBC count of > 1 X 106/ ml
- Known HIV infection
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 |
|---|---|---|
| Fairhaven Pro for menAlso: AntioxidantFairhaven Pro for men The antioxidant formula (Fairhaven Health) contains: * B12 (1000 mcg) * Zinc (30 mg) * Selenium (140 mcg) * Arginine (350 mg) * L-carnitine tartrate (2000 mg) , providing 1,340 mg of L-carnitine * CoQ10 (200 mg) * Vitamin C (120 mg) and Vitamin E (200 IU) | Drug | Patients |
| Semen analysisAlso: Semen testFull semen analysis according to WHO semen laboratory manual 5th edition will be done pre and 3 months post-treatment. After complete liquefaction, each sample was evaluated for both macroscopic parameters such as color, pH, ejaculate volume, age of the sample and viscosity. An aliquot of the sample was examined for sperm concentration, total sperm count, total and progressive motility and sperm morphology using the WHO fifth edition guidelines (WHO, 2010). Semen analysis was done manually using a hemocytometer. Sperm motility was assessed and categorized as progressive or non-progressive. Morphology was assessed by a single experienced technician using the Diff-Quik staining protocol. Kruger's strict criteria were used for morphology assessment with 4% normal morphology as a cut-off (WHO, 2010). | Diagnostic test | Patients |
| Sperm DNA fragmentationAlso: SDFSperm DNA fragmentation was evaluated using the Halosperm kit from Halotech DNA, S.L. (Madrid, Spain) as per manufacturer instructions. The method is based on the sperm chromatin dispersion test (Fernández et al., 2003). A minimum of 500 spermatozoa were scored and reported as percentage of sperm with spermatozoa with fragmented DNA. Normal value is measure at a cut-off value of more than 30% | Diagnostic test | Patients |
| Static Oxidation reduction potential in semenAlso: sORP, Oxidative stressOxidative stress was assessed by measuring the static oxidation-reduction potential (sORP) of neat liquefied semen samples using the MiOXSYSTM System (Aytu Bioscience, Inc., Englewood, USA). This is a galvanostatic measure of the electron transfer from reductants (antioxidants) to oxidants under a steady low voltage reducing current. Thus, providing an aggregate measure of all current oxidant activity and antioxidant activity in a sample. Higher sORP values (millivolts, mV) indicate a higher oxidant activity relative to the antioxidant activity and therefore greater state of oxidative stress. | Diagnostic test | Patients |
Primary outcome
Evaluate the effect of antioxidant therapy on sperm motility in infertile men,
Time frame: 1 year
Measured by mean change in sperm motility pre- and post-treatment with antioxidants.
Evaluate the effect of antioxidant therapy on sperm morphology in infertile men
Time frame: 1 year
Measured by the mean change in sperm morphology pre- and post-treatment with antioxidants
Evaluate the effect of antioxidant therapy on sperm count in infertile men
Time frame: 1 year
Measured by mean change in sperm count pre- and post-treatment with antioxidants.
2 secondary outcomes
Evaluate the effect of antioxidant therapy on sperm DNA fragmentation in infertile men
Time frame: 1 year
Evaluate the effect of antioxidant therapy on oxidative stress in infertile men
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
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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 Phase 4 study testing Fairhaven Pro for men, Semen analysis and Sperm DNA fragmentation in people with Antioxidants and Infertility, Male, run by Hamad Medical Corporation at 1 site in Qatar.
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 8 inclusion and 17 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 14 Mar 2018. 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 Qatar. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of antioxidant therapy on sperm motility in infertile men, (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2018.