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

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.

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 Overview

• Status: Completed
• Conditions: Asthenozoospermia
• Intervention / Treatment: Biological: Proxeed Plus 2*1 A arm; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Izmit
    • Kocaeli, Izmit, Turkey (Türkiye)
      • Naci Burak Çinar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; The treated group	Biological: Proxeed Plus 2*1 A arm; Proxeed plus 2 x daily sachets (2*1) three mounths
Placebo Comparator: B; The placebo group	Biological: Placebo; Placebo 2 x daily sachets (2*1) three mounths

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sperm motility (%)	semen analysis (microscopic analysis)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proteomics analysis	Water for chromatography (LC-MS Grade)	8 weeks
oxidative stress	ROS (Human SOD1(Superoxide Dismutase 1, Soluble) ELISA)	4 weeks

Collaborators and Investigators

• Sponsor: Kocaeli University
• Collaborators: ECZACIBAŞI

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: infertility; antioxidant; proteomics
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Infertility, Male; Infertility; Asthenozoospermia; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 344119007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No