NCT04509583

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

June 22, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

May 5, 2020

Last Update Submit

June 19, 2023

Conditions

Infertility, Male

Keywords

Sperm DNA fragmentationmicronutrientIn vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The impact of micro nutrients supplements on embryo quality after ICSI

    3 months

  • The impact of micro nutrients supplements on pregnancy outcomes after ICSI

    3 months

Study Arms (2)

PROFortil group

EXPERIMENTAL

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

Vitamin E group

OTHER

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

Interventions

PROFortilDIETARY_SUPPLEMENT

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

PROFortil group
Vitamin EOTHER

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

Vitamin E group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Male from infertile couples

You may not qualify if:

  • Men with acute systemic diseases
  • acute urinary tract infection
  • hepatic function disorders
  • malignant diseases
  • retrograde ejaculation
  • azoospermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hue University of Medicine and Pharmacy, Hue University

Huế, Thua Thien, 530000, Vietnam

Location

Related Publications (1)

  • Nguyen ND, Le MT, Tran NQT, Nguyen QHV, Cao TN. Micronutrient supplements as antioxidants in improving sperm quality and reducing DNA fragmentation. Basic Clin Androl. 2023 Sep 14;33(1):23. doi: 10.1186/s12610-023-00197-9.

    PMID: 37704942DERIVED

MeSH Terms

Conditions

Infertility, Male

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Minh Tam Le, M.D.,Ph.D

    Hue University of Medicine and Pharmacy, Hue University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Computerized label randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2020

First Posted

August 12, 2020

Study Start

November 18, 2019

Primary Completion

March 1, 2021

Study Completion

December 30, 2021

Last Updated

June 22, 2023

Record last verified: 2023-02

Locations

VN(1)