Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT03549533
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2018-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Aluminum on Sperm DNA Quality
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Study Overview
Official Title:
Impact of Aluminum on Sperm DeoxyriboNucleic Acid (DNA) Quality
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Between 1950 and 2013, aluminum production was multiplied by thirty in the world. Today, men's exposure to aluminum, including food products, cosmetics, air and water contamination, and a number of drugs (vaccine, gastric bandages, etc.) has never been so high and should continue to increase. At the same time, we are witnessing a decline in male fertility in Western countries.
In this context, several teams, including ours, have studied the impact of aluminum on the fertility of men. These studies have shown that aluminum accumulates in semen and especially in sperm near its DNA.
Aluminum has already shown that it is capable of damaging the DNA of various cells, especially to increase DNA fragmentation. We therefore hypothesize that aluminum could lead to increased sperm DNA fragmentation. This would result in a decrease of men fertility and in higher risk of miscarriage.
In this context, several teams, including ours, have studied the impact of aluminum on the fertility of men. These studies have shown that aluminum accumulates in semen and especially in sperm near its DNA.
Aluminum has already shown that it is capable of damaging the DNA of various cells, especially to increase DNA fragmentation. We therefore hypothesize that aluminum could lead to increased sperm DNA fragmentation. This would result in a decrease of men fertility and in higher risk of miscarriage.
Detailed Description:
In order to confirm this hypothesis, this study aims to dose aluminum in the spermatozoa of 80 patients who perform artificial insemination and correlate this result to their sperm DNA fragmentation. Patients will be recruited from the reproductive biology unit of Saint-Etienne University Hospital. Aluminum assays will be carried out using an Atomic Absorption Spectrophotometry technique by Prof. Exley at Keele University in Great Britain, a world expert in aluminum toxicity. Measurements of sperm DNA damage will be carried out using flow cytometry by our research team (SAINBIOSE INSERM U1059) at the Medecine Faculty of Saint-Etienne.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-A01825-48 | OTHER | ANSM | View |