Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date December 30, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
PROFortil
Multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months
Other:
Vitamin E
Only Vitamin E (Enat 400, once per day) in 3 months

Locations

Country Name City State
Vietnam Hue University of Medicine and Pharmacy, Hue University Hue Thua Thien

Sponsors (1)

Lead Sponsor Collaborator
Hue University of Medicine and Pharmacy

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change of DFI after micro nutrients supplements The change of sperm DNA Fragmentation Index after treatment with PROfortil in 3 months 3 months
Secondary The impact of micro nutrients supplements on embryo quality after ICSI The blastocyst quality in IVF/ICSI cycles after treatment with PROFortil 3 months
Secondary The impact of micro nutrients supplements on pregnancy outcomes after ICSI The pregnancy rate in IVF/ICSI cycles after treatment with PROFortil 3 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04142112 - Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation N/A
Recruiting NCT04955782 - Abstinence Period and Semen Quality
Recruiting NCT05506722 - Using of Testes Shocker in Improving the Spermatogenesis and Sperms Activity N/A
Not yet recruiting NCT03988361 - Selection of Non Apoptotic Human Sperm for in Vitro Fertilization by Using Magnetic Activated Cell Sorting (MACS)
Completed NCT03319654 - Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle N/A
Not yet recruiting NCT05597631 - G-IVF and Sperm Parameters N/A
Completed NCT05919186 - Effects of Antioxidant Supplementation of Culture Media on IVF Embryos N/A
Recruiting NCT03588949 - Role of Nutritional Support in Idiopathic Male Infertility N/A
Recruiting NCT03527043 - Impact of Escitalopram on Sperm DNA Fragmentation Phase 2
Completed NCT02932865 - Modern Analyses of the Semen in Evaluating Male Fertility and Treatment Options of Male Infertility
Completed NCT02310087 - Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures N/A
Completed NCT00385346 - Expressive Writing in Male Infertility N/A
Recruiting NCT04144244 - Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles N/A
Recruiting NCT04452305 - Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting N/A
Completed NCT05461079 - Sperm Phenotype and Differentially Methylated Regions
Recruiting NCT05205733 - Expanding Fertility Care to Poor and Low Resourced Settings Study N/A
Completed NCT03960229 - The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor N/A
Not yet recruiting NCT06050031 - Level of DNA-fragmentation Before and After Antioxidant-based Therapies in Male Infertility
Not yet recruiting NCT03090438 - IVF Outcomes After Varicocele Repair N/A
Recruiting NCT03968367 - To Study the Effect of Magnetic Activated Sperm Sorting on the Outcome of in Vitro Fertilization-embryo Transplantation N/A