Investigation of The Effectiveness of Antioxidant Therapy in Oligoasthenoteratozoospermic Infertile Men

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Male Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups with full (simple) randomization

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

group receiving antioxidant support

Group Type ACTIVE_COMPARATOR

proxeed plus

Intervention Type 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 2

group that did not receive antioxidant support

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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proxeed plus

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No