Investigation of The Effectiveness of Antioxidant Therapy in Oligoasthenoteratozoospermic Infertile Men

NCT06042738 | Completed

• 1 other identifier: OAT2023
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 30% of the factors that cause male infertility are due to idiopathic causes. Increased reactive oxygen species (ROS) due to many known and unknown factors cause male infertility by affecting spermatogenesis and sperm maturation. In this study, the effects of physical activity and antioxidant food supplementation on seminal antioxidant capacity, sperm DNA fragmentation index, sperm chromatin quality and sperm parameters were investigated in infertile cases.

Conditions

Male Infertility

Keywords

exercise; antioxidant; antioxidant capacity; sperm DNA fragmentation; protamine

Outcome Measures

Primary Outcomes (3)

• Total Antioxidant Capacity

  Total Antioxidant Capacity (TAC) was measured by the colorimetric assay using the antioxidant Assay Kit (Cayman Chemical, Michigan, USA). All seminal plasma samples were diluted prior to analysis. Standards were diluted sequentially. All samples and standards were placed in duplicate. Chromogen and metmyoglobin were added to both samples and standards. Hydrogen peroxide was added and then the plate was incubated. The absorbances of the standards and samples were measured at 750 nm using a microplate spectrophotometer (Multiscan GO, Thermo Scientific, Finland) after incubation. Calculations of each standard and sample were made to evaluate the assay. A standard Trolox curve was plotted with the mean absorbance of the standards. The TACs of the samples were calculated according to the formula using the linear regression of that standard curve and the average of the absorbance of samples: Antioxidant (mM) = \[(Sample average absorbance) - (y-intercept)/ Slope\] x Dilution

  3 months

• Sperm DNA Fragmentation

  Sperm DNA Fragmentation (SDF) was analysed with TUNEL using the commercial In situ Cell Death Detection Kit. All samples were fixed with 4% paraformaldehyde (PFA). Fixed sperm samples were added onto polylysine-coated slides. Slides were kept in freshly prepared permeabilization solution on ice. For TUNEL reaction, label solution was mixed with enzyme solution, and 50 µl of the mix was dropped. Slides were incubated, afterward, they were washed three times and a mounting medium with DAPI was added. Samples were immediately examined and photographed using a fluorescent microscope. Photographs were analysed with the Image J program and at least 500 cells were evaluated from each sample. SDF was calculated as the number of sperm nuclei stained green as a percentage of the total sperm nuclei identified as blue in the same area.

  3 months

• % of histone-rich spermatozoa

  Sperm pellets were washed then spread on clean slides and the smears were air dried. Dried smears were fixed with 3% glutaraldehyde and they were immersed in a 5% aniline blue solution in 4% glacial acetic acid. After staining, 200 sperm were counted at least on each slide at 1000x magnification at a light microscope. Pale blue spermatozoa that received less or no staining were considered protamine-rich, and spermatozoa partially or completely stained dark blue were evaluated as histone-rich.

  3 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

group receiving antioxidant support

Combination Product: proxeed plus

Group 2

NO INTERVENTION

group that did not receive antioxidant support

Interventions

proxeed plus COMBINATION_PRODUCT

Group 1 was recommended to receive a food supplement containing 2000 mg L-carnitine, 2000 mg fructose, 932 mg acetyl L-carnitine, 225 mg vitamin C, 115 mg citric acid, 50 mg coenzyme Q10, 14 mg zinc, 115 µg selenium, 3750 µg vitamin B12 and 500 µg folic acid as one sachet in the morning and evening

Group 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Clinical diagnosis of idiopathic oligoasthenoteratozoospermia

You may not qualify if:

• Vasectomy
• Azoospermia or severe oligozoospermia
• Current use of a treatment or drug
• Cancer, heart disease or cirrhosis history
• Uncontrolled diabetes mellitus -

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

Location

Related Publications (1)

• Sengul M, Hekim N, Asci R, Gunes S. The impact of antioxidants on antioxidant capacity, DNA fragmentation, and chromatin quality in subfertile men: a randomized clinical trial study. Rev Assoc Med Bras (1992). 2024 Nov 11;70(10):e20240211. doi: 10.1590/1806-9282.20240211. eCollection 2024.

  PMID: 39536246 DERIVED

MeSH Terms

Conditions

Infertility, Male; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Ramazan Asci

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

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

Model Details: two groups with full (simple) randomization

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: September 21, 2023
• Study Start: March 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)