Infertility, Male
Conditions
Keywords
Sperm DNA fragmentation, micronutrient, In vitro fertilization
Brief summary
Male from infertile couples are tested for semen analysis and sperm DNA fragmentation. Any case with high DNA fragmentation index (DFI) will be randomized indicated for multi-micro nutrient supplement (PROfortil™) in 3 months and then checked again post-treatment for (DFI). The IVF/ICSI cycles will be analyzed for pregnancy outcomes
Detailed description
Higher DFI is correlated with poor embryo development, lower implantation rate in intracytoplasmic sperm injection (ICSI) cycles and higher miscarriage rate. 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.
Interventions
DIETARY_SUPPLEMENTPROFortil
Multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months
OTHERVitamin E
Only Vitamin E (Enat 400, once per day) in 3 months
Sponsors
Hue University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Computerized label randomization
Intervention model description
Men from infertile couples with increased sperm DNA fragmentation will be randomized devided into 2 groups: (1) with multi-micronutrient supplements (PROFortilTM) plus Vitamin E and (2) with Vitamin E only.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
\- Male from infertile couples
Exclusion criteria
* Men with acute systemic diseases * acute urinary tract infection * hepatic function disorders * malignant diseases * retrograde ejaculation * azoospermia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of DFI after micro nutrients supplements | 3 months | The change of sperm DNA Fragmentation Index after treatment with PROfortil in 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The impact of micro nutrients supplements on embryo quality after ICSI | 3 months | The blastocyst quality in IVF/ICSI cycles after treatment with PROFortil |
| The impact of micro nutrients supplements on pregnancy outcomes after ICSI | 3 months | The pregnancy rate in IVF/ICSI cycles after treatment with PROFortil |
Countries
Vietnam
Outcome results
None listed