Impact of Aluminum on Sperm DNA Quality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-13

Study Completion Date

2021-09-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Human Sperm Markers of Cryodamage Resistance

NCT02535377

Fertility

COMPLETED

Measuring Free Radicals in Human Sperm Cells Related to Microbiota and Lifestyle Factors

NCT05514223

Infertility, Male Infertility

RECRUITING

Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle

NCT03319654

Infertility Unexplained Infertility, Male DNA Damage

COMPLETED NA

Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

NCT05846256

Infertility, Male

UNKNOWN

Effect of Long-time Human Sperm Storage in Liquid Nitrogen on Semen Parameters

NCT06448000

Healthy Cancer Infertility, Male +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Insemination, Artificial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

artificial insemination

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

samples of sperm

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

samples of sperm

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No