NCT04509583 is a NA clinical trial of PROFortil in Infertility, Male, sponsored by Hue University of Medicine and Pharmacy.

Who is sponsoring NCT04509583?

NCT04509583 is sponsored by Hue University of Medicine and Pharmacy.

What drugs are being tested in NCT04509583?

Interventions in NCT04509583: PROFortil, Vitamin E.

What condition does NCT04509583 study?

NCT04509583 studies Infertility, Male.

Is NCT04509583 still recruiting?

NCT04509583 is currently completed. Last updated 22 June 2023.

Last reviewed 2023-06-22 · How we verify

NCT04509583

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 22 June 2023

What this trial tests

NA trial testing PROFortil in Infertility, Male in 71 participants. Completed in 30 December 2021.

Timeline

18 November 2019

Primary endpoint
1 March 2021

30 December 2021

Quick facts

Lead sponsor	Hue University of Medicine and Pharmacy
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	71
Start date	18 November 2019
Primary completion	1 March 2021
Estimated completion	30 December 2021
Sites	1 location across Vietnam

Drugs / interventions tested

PROFortil
Vitamin E (VITAMIN E) — full drug profile →

Conditions studied

Infertility, Male — all drugs for Infertility, Male →

Sponsor

Hue University of Medicine and Pharmacy

Who can join

Adults 18 to 60, male only, with Infertility, Male. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Antioxidants for male subfertility.
de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, et al · · 2022 · cited 65× · PMID 35506389 · DOI 10.1002/14651858.cd007411.pub5
Micronutrient supplements as antioxidants in improving sperm quality and reducing DNA fragmentation.
Nguyen ND, Le MT, Tran NQT, Nguyen QHV, et al · · 2023 · cited 13× · PMID 37704942 · DOI 10.1186/s12610-023-00197-9

Verify or expand the search:

Other recruiting trials for Infertility, Male

Currently open trials in the same condition.

NCT06950203 — The Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality · NA · recruiting
NCT06539585 — Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality · NA · active not recruiting
NCT05514223 — Measuring Free Radicals in Human Sperm Cells Related to Microbiota and Lifestyle Factors · recruiting
NCT06841861 — Spermatogonial Differentiation Via Testicular Organoid · Phase 1, PHASE2 · recruiting
NCT05903859 — Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI) · Phase 3 · recruiting

Other Hue University of Medicine and Pharmacy trials

Trials by the same sponsor.

NCT06890104 — Effects of Mechanical, Chemical, and Combination Methods on Halitosis · NA · completed
NCT05969756 — Early Treatments for Preventing Occlusal Caries Lesions · NA · active not recruiting
NCT07115576 — Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules: A Prospective Study · NA · active not recruiting
NCT03543774 — Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population · Phase 4 · unknown
NCT03825445 — GnRH Agonist Versus hCG Trigger in Ovulation Induction With Intrauterine Insemination. · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04509583 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hue University of Medicine and Pharmacy
Last refreshed: 22 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04509583.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing