Impact of Aluminum on Sperm DNA Quality
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|ClinicalTrials.gov Identifier: NCT03549533|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : May 30, 2019
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.
|Condition or disease||Intervention/treatment|
|Insemination, Artificial||Other: samples of sperm|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||80 participants|
|Target Follow-Up Duration:||9 Months|
|Official Title:||Impact of Aluminum on Sperm DeoxyriboNucleic Acid (DNA) Quality|
|Actual Study Start Date :||June 13, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
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.
- 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.
- Spermatic DNA fragmentation [ Time Frame: Day 1 ]To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.
- Spermatic DNA methylation [ Time Frame: Day 1 ]To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.
- 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.
- 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
- Spontaneous Miscarriage [ Time Frame: Months 9 ]Analyze the rate of spontaneous miscarriage.
- Live birth [ Time Frame: Months 9 ]Analyze the rate of live birth
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549533
|Contact: Jean-Philippe KLEIN, MD||(0)477828307 ext +firstname.lastname@example.org|
|Contact: Carine LABRUYERE, CRA||(0)477120469 ext +email@example.com|
|CHU de Saint Etienne||Recruiting|
|Saint-Étienne, France, 42055|
|Principal Investigator: Jean-Philippe KLEIN, MD|
|Sub-Investigator: Isabelle AKNIN, MD|
|Sub-Investigator: Ivan MAUBON, MD|
|Sub-Investigator: Lionel MERY, MD|
|Principal Investigator:||Jean-Philippe KLEIN, MD||CHU SAINT-ETIENNE|