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

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ClinicalTrials.gov Identifier: NCT04509583
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Hue University of Medicine and Pharmacy

Study Description
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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

Condition or disease Intervention/treatment Phase
Infertility, Male Dietary Supplement: PROFortil Other: Vitamin E Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Computerized label randomization
Primary Purpose: Treatment
Official Title: Is Micro Nutrient Supplement Effective in Improving the Sperm DNA Fragmentation
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509583


Contacts
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Contact: Minh Tam Le, A.Prof 0084989228779 leminhtam@huemed-univ.edu.vn

Locations
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Vietnam
Hue University of Medicine and Pharmacy, Hue University Recruiting
Hue, Thua Thien, Vietnam, 530000
Sponsors and Collaborators
Hue University of Medicine and Pharmacy
Investigators
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Study Director: Minh Tam Le, M.D.,Ph.D Hue University of Medicine and Pharmacy, Hue University
More Information
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Responsible Party: Hue University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT04509583    
Other Study ID Numbers: H2019/433
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

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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
Keywords provided by Hue University of Medicine and Pharmacy:
Sperm DNA fragmentation
micronutrient
In vitro fertilization
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Vitamin E
Vitamins
Micronutrients
 Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents