An interventional study of Fragmented DNA evaluation in blood and semen samples in Male Infertility, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other
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.
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).
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Exclusion Criteria:
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
Other: Fragmented 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.
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
Time frame: 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
Time frame: 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
Time frame: Up to 6 months after smoking cessation
Rate of 8-OHdG gamete DNA
Time frame: Up to 12 months after smoking cessation
Spermogram exam
Spermogram examination
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
Blood samples at day 0 (before weaning), and at 3 months, 6 months, 12 months after smoking cessation
Time frame: 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
Time frame: Up to 12 months after smoking cessation
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse