Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Aluminum on Sperm DNA Quality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03549533
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment
Insemination, Artificial Other: samples of sperm

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aluminum

Group/Cohort Intervention/treatment
artificial insemination
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Samples of sperm will be analyzed.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men who perform his first artificial insemination
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549533


Contacts
Layout table for location contacts
Contact: Jean-Philippe KLEIN, MD (0)477828307 ext +33 j.philippe.klein@chu-st-etienne.fr
Contact: Carine LABRUYERE, CRA (0)477120469 ext +33 carine.labruyere@chu-st-etienne.fr

Locations
Layout table for location information
France
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Layout table for investigator information
Principal Investigator: Jean-Philippe KLEIN, MD CHU SAINT-ETIENNE

Additional Information:

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03549533     History of Changes
Other Study ID Numbers: 1708031
2017-A01825-48 ( Other Identifier: ANSM )
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Aluminum
Sperm
DNA methylation
DNA fragmentation
Seminal plasma