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

NCT ID: NCT05826782

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2024-11-20

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.

Conditions

Asthenozoospermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

A

The treated group

Group Type: ACTIVE_COMPARATOR

Proxeed Plus 2*1 A arm

Intervention Type: BIOLOGICAL

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

B

The placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Interventions

Proxeed Plus 2*1 A arm

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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 -

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ECZACIBAŞI

UNKNOWN

Sponsor Role: collaborator

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Naci Burak Cinar

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Naci Burak Çinar

Kocaeli, Izmit, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

344119007

Identifier Type: -

Identifier Source: org_study_id