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Completed

NCT Number: NCT03549533

Impact of Aluminum on Sperm 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.

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Key information

Conditions

Insemination, Artificial

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

CHU de Saint Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

samples of sperm

Other

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

Primary outcomes

  1. Aluminum content of sperm

    Time frame: Day 1

    To analyze concentration of aluminum content of sperm the day of inclusion. Aluminum content of sperm will be measured by atomic absorption spectrophotometry.

  2. Spermatic DNA fragmentation

    Time frame: Day 1

    To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.

Secondary outcomes

  1. Spermatic DNA methylation

    Time frame: Day 1

    To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.

  2. Aluminum content of seminal plasma

    Time frame: Day 1

    To analyze aluminum content of seminal plasma. Aluminum content of seminal plasma will be measured by atomic absorption spectrophotometry.

  3. HCG value

    Time frame: Weeks 2

    To analyze HCG value in the patient women. HCG value will be measured by blood sample two weeks after artificial insemination

  4. Spontaneous Miscarriage

    Time frame: Months 9

    Analyze the rate of spontaneous miscarriage.

  5. Live birth

    Time frame: Months 9

    Analyze the rate of live birth

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Impact of Aluminum on Sperm DeoxyriboNucleic Acid (DNA) Quality

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2018
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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