AsthenozoospermiaAsthenospermiaNCT05826782
Effect of Antioxidant Food Supplement on Sperm Proteomic Structure and Semen Parameters
A study testing Proxeed Plus 2*1 A arm in people with Asthenozoospermia, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Infertility is defined as the inability to become pregnant despite 12 months of regular and unprotected intercourse. Male factors include defects in sperm concentration, morphology and motility, among which low sperm motility (asthenozoospermia) is one of the most common types of male infertility and affects… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Asthenozoospermia
- What is being tested?
- Proxeed Plus 2*1 A arm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2023to 20 Nov 2024
- 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 20 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Being in the age range of 20-40
- Be infertile ( 12 months intercourse without any contraception)
- Due to infertility, you should apply to us and have a spermiogram detection of asthenozoospermia
- Patients whose spouses have normal gynecological examinations
- Patients with normal physical examinations
- Patients with normal hormonal values (FSH, LH,PRL,Testosterone,Estrogen) -
Who cannot join
- previous treatment for infertility
- Previously due to infertility or for any reason take antioxidant food supplements
- Surgery or physical examination due to varicocele detection of varicocele
- Detection of endocrine disorder (Defect in serum blends)
- Smokers and alcohol addiction
- Detection of infection in the genital tract
- Having a chronic illness -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kocaeli University
Infertility is defined as the inability to become pregnant despite 12 months of regular and unprotected intercourse. Male factors include defects in sperm concentration, morphology and motility, among which low sperm motility (asthenozoospermia) is one of the most common types of male infertility and affects approximately 40% of all cases.
It has become clear that protein defects in spermatozoa and semen can cause fertilization failure by affecting sperm motility, and it is necessary to define proteins and related pathways precisely because they have an important role in the treatment phase.
Read more
Increasing evidence shows that free oxygen radicals that occur as a result of oxidative stress (OS) play a very important role in the etiology of male infertility.
A systematic review including 29 studies (19 randomized clinical trials and 10 prospective studies) examined the effect of antioxidant food supplementation and reported a positive effect on baseline semen parameters, advanced sperm function, outcomes of assisted reproductive therapy, and live birth rate.
Conversely, few studies have failed to confirm any positive effect of antioxidant therapy and even report a negative effect on male fertility. Therefore, there is no clear consensus on the clinical efficacy of antioxidant therapy yet.
Since the pathogenesis has not yet been clearly demonstrated, treatments are not based on evidence, but based on clinical experience.
Our aim was to randomly divide infertile male patients who applied to our clinic with the complaint of infertility and found asthenozoospermia (restricted sperm motility) in their semen analysis into two arms and examine the effects of antioxidant food supplementation on sperm motility and proteomic structure with a placebo-comparative, prospective, double-blind study (LC-MS/MS). analysis) is to reveal the metabolic pathways that may lead to restriction of movement. The effect of antioxidant food support on sperm parameters and free oxygen radical levels in the control spermiogram after 3 (three) months of treatment to be given to the patients will be measured by ELISA method and compared with pre-treatment values.
- Conditions
- Asthenozoospermia
- Being tested
- Proxeed Plus 2*1 A arm, Placebo
- Keywords
- infertility, antioxidant, proteomics
- Medical subject headings
- Asthenozoospermia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proxeed Plus 2*1 A armBiological
Proxeed plus 2 x daily sachets (2*1) three mounths
PlaceboBiological
Placebo 2 x daily sachets (2*1) three mounths
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | The treated group Receives: Biological: Proxeed Plus 2*1 A arm |
| B | Placebo comparator | The placebo group Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sperm motility (%)
semen analysis (microscopic analysis)
Measured: 12 weeks
Secondary outcomes (2)
Proteomics analysis
Water for chromatography (LC-MS Grade)
Measured: 8 weeks
oxidative stress
ROS (Human SOD1(Superoxide Dismutase 1, Soluble) ELISA)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start30 Nov 2023
- Primary completion30 Aug 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthenozoospermiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Collaborators
- ECZACIBAŞI
- Responsible party
- Principal investigator, Naci Burak Cinar, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826782
- Sponsor's protocol ID
- 344119007
- Acronym
- Asthenospermia
- Status last verified
- Aug 2025
- First submitted
- 23 Mar 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kocaeli University
- ClinicalTrials.gov ID
- NCT05826782
- Acronym / sponsor ID
- Asthenospermia / 344119007
- Conditions
- Asthenozoospermia
- Keywords
- infertility, antioxidant, proteomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Collaborators
- ECZACIBAŞI
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 24 Apr 2023 (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.
Infertility is defined as the inability to become pregnant despite 12 months of regular and unprotected intercourse. Male factors include defects in sperm concentration, morphology and motility, among which low sperm motility (asthenozoospermia) is one of the most common types of male infertility and affects approximately 40% of all cases.
It has become clear that protein defects in spermatozoa and semen can cause fertilization failure by affecting sperm motility, and it is necessary to define proteins and related pathways precisely because they have an important role in the treatment phase.
Increasing evidence shows that free oxygen radicals that occur as a result of oxidative stress (OS) play a very important role in the etiology of male infertility.
A systematic review including 29 studies (19 randomized clinical trials and 10 prospective studies) examined the effect of antioxidant food supplementation and reported a positive effect on baseline semen parameters, advanced sperm function, outcomes of assisted reproductive therapy, and live birth rate.
Conversely, few studies have failed to confirm any positive effect of antioxidant therapy and even report a negative effect on male fertility. Therefore, there is no clear consensus on the clinical efficacy of antioxidant therapy yet.
Since the pathogenesis has not yet been clearly demonstrated, treatments are not based on evidence, but based on clinical experience.
Our aim was to randomly divide infertile male patients who applied to our clinic with the complaint of infertility and found asthenozoospermia (restricted sperm motility) in their semen analysis into two arms and examine the effects of antioxidant food supplementation on sperm motility and proteomic structure with a placebo-comparative, prospective, double-blind study (LC-MS/MS). analysis) is to reveal the metabolic pathways that may lead to restriction of movement. The effect of antioxidant food support on sperm parameters and free oxygen radical levels in the control spermiogram after 3 (three) months of treatment to be given to the patients will be measured by ELISA method and compared with pre-treatment values.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Biological: Proxeed Plus 2*1 A armThe treated group |
| B | Placebo comparator | Biological: PlaceboThe placebo group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being in the age range of 20-40
- Be infertile ( 12 months intercourse without any contraception)
- Due to infertility, you should apply to us and have a spermiogram detection of asthenozoospermia
- Patients whose spouses have normal gynecological examinations
- Patients with normal physical examinations
Key exclusion criteria (7 listed)
- previous treatment for infertility
- Previously due to infertility or for any reason take antioxidant food supplements
- Surgery or physical examination due to varicocele detection of varicocele
- Detection of endocrine disorder (Defect in serum blends)
- Smokers and alcohol addiction
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 |
|---|---|---|
| Proxeed Plus 2*1 A armProxeed plus 2 x daily sachets (2*1) three mounths | Biological | A |
| PlaceboPlacebo 2 x daily sachets (2*1) three mounths | Biological | B |
Primary outcome
sperm motility (%)
Time frame: 12 weeks
semen analysis (microscopic analysis)
2 secondary outcomes
Proteomics analysis
Time frame: 8 weeks
oxidative stress
Time frame: 4 weeks
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 2 Sep 2025.
- Individual participant dataSharing planned: No
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Efficacy and Safety of a New Sperm Capacitation Method
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proxeed Plus 2*1 A arm in people with Asthenozoospermia, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 2 Sep 2025. 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 Turkey (Türkiye). 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.
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?
sperm motility (%) (time frame: 12 weeks). 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 2 Sep 2025.