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NCT Number: NCT04509583

The Role of Micro Nutrient Supplement in Improvement of 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

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Key information

Conditions

Infertility, Male Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hue University of Medicine and Pharmacy, Hue University

Huế, Thua Thien, 530000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROFortil

Dietary Supplement

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

Vitamin E

Other

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

Primary outcomes

  1. The change of DFI after micro nutrients supplements

    Time frame: 3 months

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

Secondary outcomes

  1. The impact of micro nutrients supplements on embryo quality after ICSI

    Time frame: 3 months

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

  2. The impact of micro nutrients supplements on pregnancy outcomes after ICSI

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Hue University of Medicine and Pharmacy

Other

Registry information

Official study title

Is Micro Nutrient Supplement Effective in Improving the Sperm DNA Fragmentation

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2020
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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