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Effect of Antioxidant Food Supplement on Sperm Proteomic Structure and Semen Parameters

Kocaeli University

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05826782
Acronym
Asthenospermia
Enrollment
30
Registered
2023-04-24
Start date
2023-11-30
Completion date
2024-11-20
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthenozoospermia

Keywords

infertility, antioxidant, proteomics

Brief 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 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.

Interventions

BIOLOGICALProxeed Plus 2*1 A arm

Proxeed plus 2 x daily sachets (2\*1) three mounths

BIOLOGICALPlacebo

Placebo 2 x daily sachets (2\*1) three mounths

Sponsors

ECZACIBAŞI
CollaboratorUNKNOWN
Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

1. Being in the age range of 20-40 2. Be infertile ( 12 months intercourse without any contraception) 3. Due to infertility, you should apply to us and have a spermiogram detection of asthenozoospermia 4. Patients whose spouses have normal gynecological examinations 5. Patients with normal physical examinations 6. Patients with normal hormonal values (FSH, LH,PRL,Testosterone,Estrogen) -

Exclusion criteria

1. previous treatment for infertility 2. Previously due to infertility or for any reason take antioxidant food supplements 3. Surgery or physical examination due to varicocele detection of varicocele 4. Detection of endocrine disorder (Defect in serum blends) 5. Smokers and alcohol addiction 6. Detection of infection in the genital tract 7. Having a chronic illness -

Design outcomes

Primary

MeasureTime frameDescription
sperm motility (%)12 weekssemen analysis (microscopic analysis)

Secondary

MeasureTime frameDescription
Proteomics analysis8 weeksWater for chromatography (LC-MS Grade)
oxidative stress4 weeksROS (Human SOD1(Superoxide Dismutase 1, Soluble) ELISA)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026