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Impact of Aluminum on Sperm DNA Quality

Impact of Aluminum on Sperm DeoxyriboNucleic Acid (DNA) Quality

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03549533
Enrollment
80
Registered
2018-06-08
Start date
2018-06-13
Completion date
2021-09-22
Last updated
2022-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insemination, Artificial

Keywords

Aluminum, Sperm, DNA methylation, DNA fragmentation, Seminal plasma

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.

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.

Interventions

OTHERsamples of sperm

As in the usual practice during artificial insemination a samples of sperm will be collected and analyzed.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient affiliated to a social security scheme * Patient who perform his first artificial insemination * Patient who is 18 years old or more

Exclusion criteria

* Patient having expressed his refusal to participate in the study after information on the protocol and delivery of an information notice. * Patient for whom the total quantity of spermatozoa is not sufficient for separation by ascending migration (in this case all the spermatozoa from the pellet are used for the insemination) * Patient under justice protection (guardianship)

Design outcomes

Primary

MeasureTime frameDescription
Aluminum content of spermDay 1To analyze concentration of aluminum content of sperm the day of inclusion. Aluminum content of sperm will be measured by atomic absorption spectrophotometry.
Spermatic DNA fragmentationDay 1To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.

Secondary

MeasureTime frameDescription
HCG valueWeeks 2To analyze HCG value in the patient women. HCG value will be measured by blood sample two weeks after artificial insemination
Spermatic DNA methylationDay 1To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.
Live birthMonths 9Analyze the rate of live birth
Spontaneous MiscarriageMonths 9Analyze the rate of spontaneous miscarriage.
Aluminum content of seminal plasmaDay 1To analyze aluminum content of seminal plasma. Aluminum content of seminal plasma will be measured by atomic absorption spectrophotometry.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026