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

Primary Purpose

Infertility, Male

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
PROFortil
Vitamin E
Sponsored by
Hue University of Medicine and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male focused on measuring Sperm DNA fragmentation, micronutrient, In vitro fertilization

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hue University of Medicine and Pharmacy, Hue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PROFortil group

Vitamin E group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The change of DFI after micro nutrients supplements
The change of sperm DNA Fragmentation Index after treatment with PROfortil in 3 months

Secondary Outcome Measures

The impact of micro nutrients supplements on embryo quality after ICSI
The blastocyst quality in IVF/ICSI cycles after treatment with PROFortil
The impact of micro nutrients supplements on pregnancy outcomes after ICSI
The pregnancy rate in IVF/ICSI cycles after treatment with PROFortil

Full Information

First Posted
May 5, 2020
Last Updated
June 19, 2023
Sponsor
Hue University of Medicine and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT04509583
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hue University of Medicine and Pharmacy

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
Keywords
Sperm DNA fragmentation, micronutrient, In vitro fertilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
Computerized label randomization
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PROFortil group
Arm Type
Experimental
Arm Description
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.
Arm Title
Vitamin E group
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
PROFortil
Intervention Description
Multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months
Intervention Type
Other
Intervention Name(s)
Vitamin E
Intervention Description
Only Vitamin E (Enat 400, once per day) in 3 months
Primary Outcome Measure Information:
Title
The change of DFI after micro nutrients supplements
Description
The change of sperm DNA Fragmentation Index after treatment with PROfortil in 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The impact of micro nutrients supplements on embryo quality after ICSI
Description
The blastocyst quality in IVF/ICSI cycles after treatment with PROFortil
Time Frame
3 months
Title
The impact of micro nutrients supplements on pregnancy outcomes after ICSI
Description
The pregnancy rate in IVF/ICSI cycles after treatment with PROFortil
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minh Tam Le, M.D.,Ph.D
Organizational Affiliation
Hue University of Medicine and Pharmacy, Hue University
Official's Role
Study Director
Facility Information:
Facility Name
Hue University of Medicine and Pharmacy, Hue University
City
Hue
State/Province
Thua Thien
ZIP/Postal Code
530000
Country
Vietnam

12. IPD Sharing Statement

Learn more about this trial

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

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