Clinical trial NCT03549533: Impact of Aluminum on Sperm DNA Quality
Official title: Impact of Aluminum on Sperm DeoxyriboNucleic Acid (DNA) Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insemination, Artificial
Keywords: Aluminum
Sperm
DNA methylation
DNA fragmentation
Seminal plasma
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men who perform his first artificial insemination

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Aluminum content of sperm
timeFrame: Day 1
measure: Spermatic DNA fragmentation
timeFrame: Day 1
Secondary outcomes:
measure: Spermatic DNA methylation
timeFrame: Day 1
measure: Aluminum content of seminal plasma
timeFrame: Day 1
measure: HCG value
timeFrame: Weeks 2
measure: Spontaneous Miscarriage
timeFrame: Months 9
measure: Live birth
timeFrame: Months 9
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Philippe KLEIN, MD
role: PRINCIPAL_INVESTIGATOR
References: