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Tobacco and Sperm Genome: Effects of Smoking Cessation

Tobacco and Sperm Genome: Effects of Smoking Cessation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03552081
Acronym
TABAGERM
Enrollment
25
Registered
2018-06-11
Start date
2018-10-02
Completion date
2022-06-21
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Keywords

spermatogenesis, tobacco, DNA Fragmentation Index

Brief 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 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).

Interventions

OTHERFragmented DNA evaluation in blood and semen samples

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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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) * 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)

Design outcomes

Primary

MeasureTime frameDescription
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 12 months after smoking cessationUp to 12 months after smoking cessationTUNEL 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 cessationUp to 3 months after smoking cessationTUNEL 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 cessationUp to 6 months after smoking cessationTUNEL 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

Secondary

MeasureTime frameDescription
Spermogram examUp to 12 months after smoking cessationSpermogram examination
Fragmentation index (DFI) of gamete DNAUp to 12 months after smoking cessation
Testosterone levelsUp to 12 months after smoking cessationBlood samples at day 0 (before weaning), and at 3 months, 6 months, 12 months after smoking cessation
luteinizing hormone (LH) levels luteinizing hormone (LH) levels luteinizing hormone (LH) levelsUp to 12 months after smoking cessationBlood samples at day 0 (before weaning), and at 3 months, 6 months, 12 months after smoking cessation
Aneuploid sperm countUp to 12 months after smoking cessation
Rate of 8-OHdG gamete DNAUp to 12 months after smoking cessation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026