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

NCT05826782 | Completed DMC

• 1 other identifier: 344119007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

infertility; antioxidant; proteomics

Outcome Measures

Primary Outcomes (1)

• sperm motility (%)

  semen analysis (microscopic analysis)

  12 weeks

Secondary Outcomes (2)

• Proteomics analysis

  8 weeks

• oxidative stress

  4 weeks

Study Arms (2)

A

ACTIVE COMPARATOR

The treated group

Biological: Proxeed Plus 2*1 A arm

B

PLACEBO COMPARATOR

The placebo group

Biological: Placebo

Interventions

Proxeed Plus 2*1 A arm BIOLOGICAL

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

A

Placebo BIOLOGICAL

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

B

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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) -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Kocaeli University: lead
• ECZACIBAŞI: collaborator

Study Sites (1)

Naci Burak Çinar

Kocaeli, Izmit, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthenozoospermia; Infertility

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 24, 2023
• Study Start: November 30, 2023
• Primary Completion: August 30, 2024
• Study Completion: November 20, 2024
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)