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

Asthenozoospermia Clinical Trial

— Asthenospermia  

Official title:

Kocaeli University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826782
• Other study ID #: 344119007
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: February 25, 2024

Study information

• Verified date: November 2023
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 25, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Asthenozoospermia

Intervention

Biological:
• Proxeed Plus 2*1 A arm
Proxeed plus 2 x daily sachets (2*1) three mounths
• Placebo
Placebo 2 x daily sachets (2*1) three mounths

Locations

Country	Name	City	State
Turkey	Naci Burak Çinar	Kocaeli	Izmit

Sponsors (2)

Lead Sponsor	Collaborator
Kocaeli University	ECZACIBASI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sperm motility (%)	semen analysis (microscopic analysis)	12 weeks
Secondary	Proteomics analysis	Water for chromatography (LC-MS Grade)	8 weeks
Secondary	oxidative stress	ROS (Human SOD1(Superoxide Dismutase 1, Soluble) ELISA)	4 weeks