Male InfertilityTABAGERMNCT03552081
Tobacco and Sperm Genome: Effects of Smoking Cessation
A study testing Fragmented DNA evaluation in blood and semen samples in people with Male Infertility, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Tobacco is a male infertility risk factor. Many studies comparing smokers to non-smokers have shown effects on spermatogenesis and the quality of the male gamete. In vitro fertilization success rates are decreased in smokers and in natural procreation the time required to conceive (excellent fertility indicator) seems… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- Fragmented DNA evaluation in blood and semen samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2018to 21 Jun 2022
- Phase
- Interventional
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1st Consultation in the Tobacco Control Co-ordination Unit,
- Affiliate or beneficiary of a social security scheme
- Free, informed and written consent signed by the participant and the investigator
Who cannot join
- febrile state during the 3 months before inclusion,
- antecedent consultation for male infertility,
- BMI> 30,
- Medical and / or surgical history that can alter spermatogenesis -Chemotherapy / Radiation Therapy / IRA-therapy, Cryptorchidism, testicular Torsion, significant varicocele, chronic, progressive disease,
- hypovolemia <1.6ml
- Major persons protected by law (guardianship, curators, safeguarding of justice)
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- Patients in periods of exclusion for another clinical research protocol
- Co-addiction (cannabis, alcohol, other drugs)
- Neuropsychiatric Pathology, considered serious by the investigator
- Psychotropic treatment (antidepressant, anxiolytic, antipsychotic)
Trial locations and contacts
1 site in 1 country.
About this study
Tobacco is a male infertility risk factor. Many studies comparing smokers to non-smokers have shown effects on spermatogenesis and the quality of the male gamete. In vitro fertilization success rates are decreased in smokers and in natural procreation the time required to conceive (excellent fertility indicator) seems to be lengthened in the smoker. The prospective study that the investigators propose to carry out would make it possible to know the time required for the repair of the sperm abnormalities and in particular the DNA of the gametes generated by the smoking.
Read the detailed description
Tobacco is a male infertility risk factor. Many studies comparing smokers to non-smokers have shown effects on spermatogenesis and the quality of the male gamete. In vitro fertilization success rates are decreased in smokers and in natural procreation the time required to conceive (excellent fertility indicator) seems to be lengthened in the smoker. Tobacco is a well-known mutagen. It will induce damage to the male gametes DNA. Tobacco increases the oxydation of DNA. Exposure to tobacco increases the percentage of spermatozoa with broken DNA or defective chromatin and induces gametes aneuploidy as has been reported in several studies. The set of effects of tobacco on the male gametes questions the consequences for the conceptus (from embryo to adult). The prospective study that the investigators propose to carry out would make it possible to know the time required for the repair of the sperm abnormalities and in particular the DNA of the gametes generated by the smoking. Indeed, a cycle of spermatogenesis extending over 74 days, it would be important to know if it is necessary to wait a complete cycle or even more before proposing a management. It would therefore be possible to find the most favorable period for reducing tobacco-related risks and for effective management.
A blood test will be performed at T0 (before weaning) and during follow-up at 3, 6 and 12 months for the determination of the Inhibin hormones and testosterone. Sperm analysis at the different follow-up times will be carried out at CECOS using a standardized methodology (WHO). Two tests of analysis will be used in this study on each sample: the TUNEL test and the SCSA. A measurement of DNA oxidation will also be performed, as well as a study of spermatic aneuploidy (in situ hybridization technique of fluorescent centromeric chromosomal probes).
- Conditions
- Male Infertility
- Being tested
- Fragmented DNA evaluation in blood and semen samples
- Keywords
- spermatogenesis, tobacco, DNA Fragmentation Index
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fragmented DNA evaluation in blood and semen samplesOther
The objective will be to evaluate the decrease in the percentage of sperm with spermatic DNA fragmentation by the TUNEL technique following the evolution of this rate to 3 months, 6 months and 12 months after cessation of smoking by blood and semen samples.
| Study group | Role | What they receive |
|---|---|---|
| fragmented DNA evaluation in blood and semen samples | Experimental | 20 men followed for smoking cessation will be included in the study in order to evaluate the time required for the repair of the sperm abnormalities and in particular the DNA of the gametes generated by the smoking Receives: Other: Fragmented DNA evaluation in blood and semen samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 12 months after smoking cessation
TUNEL technique will be performed to evaluate the percentage of spermatozoa presenting a fragmented DNA at day 0 (before weaning = baseline), and 12 months after smoking cessation
Measured: Up to 12 months after smoking cessation
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 3 months after smoking cessation
TUNEL technique will be performed to evaluate the percentage of spermatozoa presenting a fragmented DNA at day 0 (before weaning = baseline), and 3 months after smoking cessation
Measured: Up to 3 months after smoking cessation
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 6 months after smoking cessation
TUNEL technique will be performed to evaluate the percentage of spermatozoa presenting a fragmented DNA at day 0 (before weaning = baseline), and 6 months after smoking cessation
Measured: Up to 6 months after smoking cessation
Secondary outcomes (6)
Rate of 8-OHdG gamete DNA
Measured: Up to 12 months after smoking cessation
Spermogram exam
Spermogram examination
Measured: Up to 12 months after smoking cessation
Fragmentation index (DFI) of gamete DNA
Measured: Up to 12 months after smoking cessation
Aneuploid sperm count
Measured: Up to 12 months after smoking cessation
luteinizing hormone (LH) levels luteinizing hormone (LH) levels luteinizing hormone (LH) levels
Blood samples at day 0 (before weaning), and at 3 months, 6 months, 12 months after smoking cessation
Measured: Up to 12 months after smoking cessation
Testosterone levels
Blood samples at day 0 (before weaning), and at 3 months, 6 months, 12 months after smoking cessation
Measured: Up to 12 months after smoking cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start2 Oct 2018
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Moreau, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552081
- Sponsor's protocol ID
- RC31/17/0344
- Acronym
- TABAGERM
- Status last verified
- Jul 2022
- First submitted
- 25 Apr 2018
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco and Sperm Genome: Effects of Smoking Cessation
- ClinicalTrials.gov ID
- NCT03552081
- Acronym / sponsor ID
- TABAGERM / RC31/17/0344
- Conditions
- Male Infertility
- Keywords
- spermatogenesis, tobacco, DNA Fragmentation Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 11 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.
Tobacco is a male infertility risk factor. Many studies comparing smokers to non-smokers have shown effects on spermatogenesis and the quality of the male gamete. In vitro fertilization success rates are decreased in smokers and in natural procreation the time required to conceive (excellent fertility indicator) seems to be lengthened in the smoker. The prospective study that the investigators propose to carry out would make it possible to know the time required for the repair of the sperm abnormalities and in particular the DNA of the gametes generated by the smoking.
Detailed description
Tobacco is a male infertility risk factor. Many studies comparing smokers to non-smokers have shown effects on spermatogenesis and the quality of the male gamete. In vitro fertilization success rates are decreased in smokers and in natural procreation the time required to conceive (excellent fertility indicator) seems to be lengthened in the smoker. Tobacco is a well-known mutagen. It will induce damage to the male gametes DNA. Tobacco increases the oxydation of DNA. Exposure to tobacco increases the percentage of spermatozoa with broken DNA or defective chromatin and induces gametes aneuploidy as has been reported in several studies. The set of effects of tobacco on the male gametes questions the consequences for the conceptus (from embryo to adult). The prospective study that the investigators propose to carry out would make it possible to know the time required for the repair of the sperm abnormalities and in particular the DNA of the gametes generated by the smoking. Indeed, a cycle of spermatogenesis extending over 74 days, it would be important to know if it is necessary to wait a complete cycle or even more before proposing a management. It would therefore be possible to find the most favorable period for reducing tobacco-related risks and for effective management.
A blood test will be performed at T0 (before weaning) and during follow-up at 3, 6 and 12 months for the determination of the Inhibin hormones and testosterone. Sperm analysis at the different follow-up times will be carried out at CECOS using a standardized methodology (WHO). Two tests of analysis will be used in this study on each sample: the TUNEL test and the SCSA. A measurement of DNA oxidation will also be performed, as well as a study of spermatic aneuploidy (in situ hybridization technique of fluorescent centromeric chromosomal probes).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fragmented DNA evaluation in blood and semen samples | Experimental | Other: Fragmented DNA evaluation in blood and semen samples20 men followed for smoking cessation will be included in the study in order to evaluate the time required for the repair of the sperm abnormalities and in particular the DNA of the gametes generated by the smoking |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1st Consultation in the Tobacco Control Co-ordination Unit,
- Affiliate or beneficiary of a social security scheme
- Free, informed and written consent signed by the participant and the investigator
Key exclusion criteria (10 listed)
- febrile state during the 3 months before inclusion,
- antecedent consultation for male infertility,
- BMI> 30,
- Medical and / or surgical history that can alter spermatogenesis -Chemotherapy / Radiation Therapy / IRA-therapy, Cryptorchidism, testicular Torsion, significant varicocele, chronic, progressive disease,
- hypovolemia <1.6ml
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 |
|---|---|---|
| Fragmented DNA evaluation in blood and semen samplesThe objective will be to evaluate the decrease in the percentage of sperm with spermatic DNA fragmentation by the TUNEL technique following the evolution of this rate to 3 months, 6 months and 12 months after cessation of smoking by blood and semen samples. | Other | fragmented DNA evaluation in blood and semen samples |
Primary outcome
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 12 months after smoking cessation
Time frame: Up to 12 months after smoking cessation
TUNEL technique will be performed to evaluate the percentage of spermatozoa presenting a fragmented DNA at day 0 (before weaning = baseline), and 12 months after smoking cessation
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 3 months after smoking cessation
Time frame: Up to 3 months after smoking cessation
TUNEL technique will be performed to evaluate the percentage of spermatozoa presenting a fragmented DNA at day 0 (before weaning = baseline), and 3 months after smoking cessation
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 6 months after smoking cessation
Time frame: Up to 6 months after smoking cessation
TUNEL technique will be performed to evaluate the percentage of spermatozoa presenting a fragmented DNA at day 0 (before weaning = baseline), and 6 months after smoking cessation
6 secondary outcomes
Rate of 8-OHdG gamete DNA
Time frame: Up to 12 months after smoking cessation
Spermogram exam
Time frame: Up to 12 months after smoking cessation
Fragmentation index (DFI) of gamete DNA
Time frame: Up to 12 months after smoking cessation
Aneuploid sperm count
Time frame: Up to 12 months after smoking cessation
luteinizing hormone (LH) levels luteinizing hormone (LH) levels luteinizing hormone (LH) levels
Time frame: Up to 12 months after smoking cessation
Testosterone levels
Time frame: Up to 12 months after smoking cessation
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 19 Jul 2022.
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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.
Jessica Moreau, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fragmented DNA evaluation in blood and semen samples in people with Male Infertility, run by University Hospital, Toulouse 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 10 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 19 Jul 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?
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 12 months after smoking cessation (time frame: Up to 12 months after smoking cessation). The study lists 3 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 19 Jul 2022.