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

Is Micro Nutrient Supplement Effective in Improving the Sperm DNA Fragmentation

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

Study Overview

• Status: Completed
• Conditions: Infertility, Male
• Intervention / Treatment: Dietary supplement: PROFortil; Other: Vitamin E

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minh Tam Le, A.Prof; Phone Number: 0084989228779; Email: leminhtam@huemed-univ.edu.vn

Study Locations

• Vietnam
  • Thua Thien
    • Hue, Thua Thien, Vietnam, 530000
      • Hue University of Medicine and Pharmacy, Hue University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROFortil group; Men with increased sperm DNA fragmentation (>=30%) will be indicated for multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months then checked again post-treatment for DF). The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage.	Dietary supplement: PROFortil; Multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months
Other: Vitamin E group; Any case with high DNA fragmentation index (DFI >=30%) will be randomized indicated only Vitamin E (Enat 400 once per day) in 3 months 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.	Other: Vitamin E; Only Vitamin E (Enat 400, once per day) in 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The impact of micro nutrients supplements on embryo quality after ICSI	The blastocyst quality in IVF/ICSI cycles after treatment with PROFortil	3 months
The impact of micro nutrients supplements on pregnancy outcomes after ICSI	The pregnancy rate in IVF/ICSI cycles after treatment with PROFortil	3 months

Collaborators and Investigators

• Sponsor: Hue University of Medicine and Pharmacy
• Investigators: Study Director: Minh Tam Le, M.D.,Ph.D, Hue University of Medicine and Pharmacy, Hue University

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: In vitro fertilization; Sperm DNA fragmentation; micronutrient
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Infertility; Infertility, Male; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E
• Other Study ID Numbers: H2019/433

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes