The Role of Micro Nutrient Supplement in Improvement of the Sperm DNA Fragmentation
NCT ID: NCT04509583
Last Updated: 2023-06-22
Study Results
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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COMPLETED
NA
71 participants
INTERVENTIONAL
2019-11-18
2021-12-30
Brief Summary
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Detailed Description
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The effectiveness of micro nutrients (PROfortil™) has been proven in improving sperm quality including sperm cell density, progressive motility and normal morphology.
This randomized controlled trial includes male from infertile couples treated at the Center for Reproductive Endocrinology and Infertility, Hue University hospital, Vietnam from November 2019 to November 2020.
The semen samples were collected from the husband after 3-5 days of abstinence and then evaluated for sperm motility, vitality, concentration and morphology by the guideline of World Health Organization (WHO) 2010.
Sperm DNA fragmentation (SDF) was measured using a sperm chromatin dispersion (SCD) test (Halosperm® kit, Halotech, Madrid, Spain). A total of 500 sperms were examined by only one highly trained technician to decrease variability. DFI was expressed as the percentage of sperms with small halo, without halo and degraded sperms over total of 500 sperms.
Any case with high DNA fragmentation index (DFI \>=30%) will be randomized indicated for (group 1) micro nutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months and (group 2) only Vitamin E (Enat 400 once per day) then checked again post-treatment for (DFI).
The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PROFortil group
Men with increased sperm DNA fragmentation (\>=30%) will be indicated for multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months then checked again post-treatment for DF).
The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage.
PROFortil
Multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months
Vitamin E group
Any case with high DNA fragmentation index (DFI \>=30%) will be randomized indicated only Vitamin E (Enat 400 once per day) in 3 months then checked again post-treatment for (DFI).
The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage.
Vitamin E
Only Vitamin E (Enat 400, once per day) in 3 months
Interventions
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PROFortil
Multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months
Vitamin E
Only Vitamin E (Enat 400, once per day) in 3 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* acute urinary tract infection
* hepatic function disorders
* malignant diseases
* retrograde ejaculation
* azoospermia
18 Years
60 Years
MALE
No
Sponsors
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Hue University of Medicine and Pharmacy
OTHER
Responsible Party
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Principal Investigators
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Minh Tam Le, M.D.,Ph.D
Role: STUDY_DIRECTOR
Hue University of Medicine and Pharmacy, Hue University
Locations
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Hue University of Medicine and Pharmacy, Hue University
Huế, Thua Thien, Vietnam
Countries
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References
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Nguyen ND, Le MT, Tran NQT, Nguyen QHV, Cao TN. Micronutrient supplements as antioxidants in improving sperm quality and reducing DNA fragmentation. Basic Clin Androl. 2023 Sep 14;33(1):23. doi: 10.1186/s12610-023-00197-9.
Other Identifiers
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H2019/433
Identifier Type: -
Identifier Source: org_study_id
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