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Clinical trial

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

ID
Name
OAT2023
Description
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.
Trial arms
Trial start
2021-03-01
Estimated PCD
2021-11-01
Trial end
2021-11-01
Status
Completed
Treatment
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
Arms:
Group 1
Size
48
Primary endpoint
Total Antioxidant Capacity
3 months
Sperm DNA Fragmentation
3 months
% of histone-rich spermatozoa
3 months
Eligibility criteria
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 -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two groups with full (simple) randomization', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2023-09-21

1 organization

1 product

1 indication

Organization
Ondokuz Mayıs University
Product
Proxeed Plus
Indication
Male Infertility