Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04509583 |
| Other study ID # |
H2019/433 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 18, 2019 |
| Est. completion date |
December 30, 2021 |
Study information
| Verified date |
February 2023 |
| Source |
Hue University of Medicine and Pharmacy |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
