Clinical trial NCT04509583: The Role of Micro Nutrient Supplement in Improvement of the Sperm DNA Fragmentation
Official title: Is Micro Nutrient Supplement Effective in Improving the Sperm DNA Fragmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Male
Keywords: Sperm DNA fragmentation
micronutrient
In vitro fertilization
Lead sponsor: Hue University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of DFI after micro nutrients supplements
timeFrame: 3 months
Secondary outcomes:
measure: The impact of micro nutrients supplements on embryo quality after ICSI
timeFrame: 3 months
measure: The impact of micro nutrients supplements on pregnancy outcomes after ICSI
timeFrame: 3 months
Other outcomes:
Locations:
city: Hue
country: Vietnam
facility: Hue University of Medicine and Pharmacy, Hue University
state: Thua Thien
Study officials:
affiliation: Hue University of Medicine and Pharmacy, Hue University
name: Minh Tam Le, M.D.,Ph.D
role: STUDY_DIRECTOR
References: