Clinical trial NCT06042738: Investigation of The Effectiveness of Antioxidant Therapy in Oligoasthenoteratozoospermic Infertile Men
Official title: The Impact of Antioxidant Food Supplementation on Seminal Antioxidant Capacity, Sperm DNA Fragmentation and Sperm Chromatin Quality in Subfertile Men With Oligoastenoteratozoospermia Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Keywords: exercise
antioxidant
antioxidant capacity
sperm DNA fragmentation
protamine
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups with full (simple) randomization
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Material and Method: The study included subfertile men with idiopathic oligoasthenoteratozospermia seen at Ondokuz Mayıs University Faculty of Medicine between March 2021 and November 2021.

All subjects were recommended to do moderate physical activity for at least 45 minutes (at least 150 minutes-600 METs per week) 3-4 days a week for three months. A total of 48 cases were divided into two groups by computer-assisted (www.randomizer.org) complete (simple) randomization. In the first group (Group 1), 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 Food supplement containing vitamin B12 and 500 µg folic acid was recommended as one sachet in the morning and evening, while antioxidant food supplement was not given to the second group (group 2). Before and after treatment, semen parameters, Hormone analyzes with ELISA method, physical activity evaluation with IPAQ questionnaire, seminal antioxidant capacity with Trolox equivalent antioxidant capacity (TEAC) measurement method, DNA fragmentation index with TUNEL method. and sperm chromatin structure was evaluated by aniline blue staining.

Student's t test was used for the variables showing normal distribution in independent groups, and Mann Whitney U test was used for the variables that did not fit the normal distribution. Paired t test was used for the variables showing normal distribution in the dependent groups, and Wilcoxon test was used for the variables that were found not to fit the normal distribution.

Eligibility criteria: Inclusion Criteria:

1) Clinical diagnosis of idiopathic oligoasthenoteratozoospermia

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Exclusion Criteria:

1. Vasectomy
2. Azoospermia or severe oligozoospermia
3. Current use of a treatment or drug
4. Cancer, heart disease or cirrhosis history
5. Uncontrolled diabetes mellitus -

Primary outcomes:
measure: Total Antioxidant Capacity
timeFrame: 3 months
measure: Sperm DNA Fragmentation
timeFrame: 3 months
measure: % of histone-rich spermatozoa
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: Ramazan Asci
role: STUDY_DIRECTOR
References: