Impact of Aluminum on Sperm DNA Quality

Impact of Aluminum on Sperm DeoxyriboNucleic Acid (DNA) Quality

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.

Study Overview

• Status: Completed
• Conditions: Insemination, Artificial
• Intervention / Treatment: Other: samples of sperm

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Men who perform his first artificial insemination

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
artificial insemination; Patient who perform his first artificial insemination will be included. Samples of sperm will be analyzed.	Other: samples of sperm; As in the usual practice during artificial insemination a samples of sperm will be collected and analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aluminum content of sperm	To analyze concentration of aluminum content of sperm the day of inclusion. Aluminum content of sperm will be measured by atomic absorption spectrophotometry.	Day 1
Spermatic DNA fragmentation	To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spermatic DNA methylation	To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.	Day 1
Aluminum content of seminal plasma	To analyze aluminum content of seminal plasma. Aluminum content of seminal plasma will be measured by atomic absorption spectrophotometry.	Day 1
HCG value	To analyze HCG value in the patient women. HCG value will be measured by blood sample two weeks after artificial insemination	Weeks 2
Spontaneous Miscarriage	Analyze the rate of spontaneous miscarriage.	Months 9
Live birth	Analyze the rate of live birth	Months 9

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Jean-Philippe KLEIN, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 13, 2018
• Primary Completion (ACTUAL): September 7, 2021
• Study Completion (ACTUAL): September 22, 2021

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (ACTUAL): June 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: DNA methylation; Sperm; DNA fragmentation; Aluminum; Seminal plasma
• Other Study ID Numbers: 1708031; 2017-A01825-48 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No