Insemination, Artificial Clinical Trial
Official title:
Impact of Aluminum on Sperm DeoxyriboNucleic Acid (DNA) Quality
| Verified date | March 2022 |
| Source | Centre Hospitalier Universitaire de Saint Etienne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | September 22, 2021 |
| Est. primary completion date | September 7, 2021 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Saint Etienne | Saint-Étienne |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Saint Etienne |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Day 1 | |
| Primary | Spermatic DNA fragmentation | To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical. | Day 1 | |
| Secondary | Spermatic DNA methylation | To analyze Spermatic DNA fragmentation. Spermatic DNA fragmentation will be measured by flow cytometry technical. | Day 1 | |
| Secondary | Aluminum content of seminal plasma | To analyze aluminum content of seminal plasma. Aluminum content of seminal plasma will be measured by atomic absorption spectrophotometry. | Day 1 | |
| Secondary | HCG value | To analyze HCG value in the patient women. HCG value will be measured by blood sample two weeks after artificial insemination | Weeks 2 | |
| Secondary | Spontaneous Miscarriage | Analyze the rate of spontaneous miscarriage. | Months 9 | |
| Secondary | Live birth | Analyze the rate of live birth | Months 9 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00816387 -
Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle
|
N/A |