Investigation of The Effectiveness of Antioxidant Therapy in Oligoasthenoteratozoospermic Infertile Men

Ondokuz Mayıs University

Status: Completed

Conditions: Male Infertility

Treatments: Combination Product: proxeed plus

Study type: Interventional

Funder types: Other

Identifiers

NCT06042738

OAT2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of idiopathic oligoasthenoteratozoospermia

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 -

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Group 1

Active Comparator group

Description:

group receiving antioxidant support

Treatment:

Combination Product: proxeed plus

Group 2

No Intervention group

Description:

group that did not receive antioxidant support