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

Primary Purpose

Asthenozoospermia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Proxeed Plus 2*1 A arm
Placebo
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthenozoospermia focused on measuring infertility, antioxidant, proteomics

Eligibility Criteria

20 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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) - Exclusion Criteria: 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 -

Sites / Locations

  • Naci Burak ÇinarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

The treated group

The placebo group

Outcomes

Primary Outcome Measures

sperm motility (%)
semen analysis (microscopic analysis)

Secondary Outcome Measures

Proteomics analysis
Water for chromatography (LC-MS Grade)
oxidative stress
ROS (Human SOD1(Superoxide Dismutase 1, Soluble) ELISA)

Full Information

First Posted
March 23, 2023
Last Updated
October 2, 2023
Sponsor
Kirsehir Ahi Evran University
Collaborators
ECZACIBAŞI
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1. Study Identification

Unique Protocol Identification Number
NCT05826782
Brief Title
Effect of Antioxidant Food Supplement on Sperm Proteomic Structure and Semen Parameters
Acronym
Asthenospermia
Official Title
Kocaeli University
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
Collaborators
ECZACIBAŞI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthenozoospermia
Keywords
infertility, antioxidant, proteomics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
The treated group
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
The placebo group
Intervention Type
Biological
Intervention Name(s)
Proxeed Plus 2*1 A arm
Intervention Description
Proxeed plus 2 x daily sachets (2*1) three mounths
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo 2 x daily sachets (2*1) three mounths
Primary Outcome Measure Information:
Title
sperm motility (%)
Description
semen analysis (microscopic analysis)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proteomics analysis
Description
Water for chromatography (LC-MS Grade)
Time Frame
8 weeks
Title
oxidative stress
Description
ROS (Human SOD1(Superoxide Dismutase 1, Soluble) ELISA)
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) - Exclusion Criteria: 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 -
Facility Information:
Facility Name
Naci Burak Çinar
City
Kocaeli
State/Province
Izmit
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NACİ BURAK ÇINAR
Phone
05384658110
Email
n.burak.cinar@gmail.com

12. IPD Sharing Statement

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

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