CompletedNCT03549533Updated Mar 11, 2022

Impact of Aluminum on Sperm DNA Quality

An observational study in Insemination, Artificial, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-11.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 80
Ages: 18 Years and older
Sex: Male

Study 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.

Read the 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.

Conditions studied

Insemination, Artificial

Keywords

Aluminum
Sperm
DNA methylation
DNA fragmentation
Seminal plasma

In context

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Men who perform his first artificial insemination

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Observational model: Other
Time perspective: Prospective
Enrollment: 80 participants (actual)
Target follow-up: 9 Months
Patient registry: Yes
Biospecimen retention: Samples with dna

Groups and cohorts

artificial insemination
Patient who perform his first artificial insemination will be included. Samples of sperm will be analyzed.
Other: samples of sperm

Interventions

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

What researchers measure

Primary outcomes

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.
Time frame: Day 1
Spermatic DNA fragmentation
To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.
Time frame: Day 1

Secondary outcomes

Spermatic DNA methylation
To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.
Time frame: 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.
Time frame: 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
Time frame: Weeks 2
Spontaneous Miscarriage
Analyze the rate of spontaneous miscarriage.
Time frame: Months 9
Live birth
Analyze the rate of live birth
Time frame: Months 9

Study locations

1 site

CHU de Saint Etienne
Saint-Etienne, 42055, France

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Sep 2021, 38 months.

How these figures are worked out, and which studies are left out of them.

Registered: May 25, 2018
First posted: Jun 8, 2018
StartActual: Jun 13, 2018
Primary completionActual: Sep 7, 2021
CompletionActual: Sep 22, 2021
Last update: Mar 11, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03549533
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Responsible party: Sponsor
First posted: Jun 8, 2018
Start date: Jun 13, 2018
Primary completion: Sep 7, 2021
Completion: Sep 22, 2021
Last update: Mar 11, 2022

Study contacts

Jean-Philippe KLEIN, MD

principal investigator · Centre Hospitalier Universitaire de Saint Etienne

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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