Insemination, ArtificialNCT03549533
Impact of Aluminum on Sperm DNA Quality
An observational study of Insemination, Artificial, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Insemination, Artificial
- What is being tested?
- samples of sperm
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2018to 22 Sep 2021
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men who perform his first artificial insemination
Who may be able to join
- Patient affiliated to a social security scheme
- Patient who perform his first artificial insemination
- Patient who is 18 years old or more
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Aluminum on Sperm DeoxyriboNucleic Acid (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.
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
- Insemination, Artificial
- Being tested
- samples of sperm
- Keywords
- Aluminum, Sperm, DNA methylation, DNA fragmentation, Seminal plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
samples of spermOther
As in the usual practice during artificial insemination a samples of sperm will be collected and analyzed.
| Study group | Role | What they receive |
|---|---|---|
| artificial insemination | Patient who perform his first artificial insemination will be included. Samples of sperm will be analyzed. Receives: Other: samples of sperm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Spermatic DNA fragmentation
To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.
Measured: Day 1
Secondary outcomes (5)
Spermatic DNA methylation
To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical.
Measured: 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.
Measured: 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
Measured: Weeks 2
Spontaneous Miscarriage
Analyze the rate of spontaneous miscarriage.
Measured: Months 9
Live birth
Analyze the rate of live birth
Measured: Months 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start13 Jun 2018
- Primary completion7 Sep 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insemination, ArtificialStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe KLEIN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549533
- Sponsor's protocol ID
- 1708031
- Other IDs
- 2017-A01825-48
- Status last verified
- Mar 2022
- First submitted
- 25 May 2018
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aluminum on Sperm DeoxyriboNucleic Acid (DNA) Quality
- ClinicalTrials.gov ID
- NCT03549533
- Acronym / sponsor ID
- 1708031
- Conditions
- Insemination, Artificial
- Keywords
- Aluminum, Sperm, DNA methylation, DNA fragmentation, Seminal plasma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| artificial insemination | – | Other: samples of spermPatient who perform his first artificial insemination will be included. Samples of sperm will be analyzed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men who perform his first artificial insemination
Key inclusion criteria (3 listed)
- Patient affiliated to a social security scheme
- Patient who perform his first artificial insemination
- Patient who is 18 years old or more
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| samples of spermAs in the usual practice during artificial insemination a samples of sperm will be collected and analyzed. | Other | artificial insemination |
Primary outcome
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.
5 secondary outcomes
Spermatic DNA methylation
Time frame: Day 1
Aluminum content of seminal plasma
Time frame: Day 1
HCG value
Time frame: Weeks 2
Spontaneous Miscarriage
Time frame: Months 9
Live birth
Time frame: Months 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe KLEIN, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insemination, Artificial, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aluminum content of sperm (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.