The Role of Micro Nutrient Supplement in Improvement of the Sperm DNA Fragmentation

Hue University of Medicine and Pharmacy71 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Infertility, Male

Interventions

PROFortilDIETARY_SUPPLEMENT

Multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months

Vitamin EOTHER

Only Vitamin E (Enat 400, once per day) in 3 months

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Hue University of Medicine and Pharmacy, Hue University

Huế, Thua Thien, Vietnam

Outcomes

Primary Outcomes

The change of DFI after micro nutrients supplements

The change of sperm DNA Fragmentation Index after treatment with PROfortil in 3 months

Time frame: 3 months

Secondary Outcomes

The impact of micro nutrients supplements on embryo quality after ICSI

The blastocyst quality in IVF/ICSI cycles after treatment with PROFortil

Time frame: 3 months

The impact of micro nutrients supplements on pregnancy outcomes after ICSI

The pregnancy rate in IVF/ICSI cycles after treatment with PROFortil

Time frame: 3 months

Data from ClinicalTrials.gov

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