Clinical trial NCT03552081: Tobacco and Sperm Genome: Effects of Smoking Cessation
Official title: Tobacco and Sperm Genome: Effects of Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Keywords: spermatogenesis
tobacco
DNA Fragmentation Index
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 12 months after smoking cessation
timeFrame: Up to 12 months after smoking cessation
measure: Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 3 months after smoking cessation
timeFrame: Up to 3 months after smoking cessation
measure: Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 6 months after smoking cessation
timeFrame: Up to 6 months after smoking cessation
Secondary outcomes:
measure: Rate of 8-OHdG gamete DNA
timeFrame: Up to 12 months after smoking cessation
measure: Spermogram exam
timeFrame: Up to 12 months after smoking cessation
measure: Fragmentation index (DFI) of gamete DNA
timeFrame: Up to 12 months after smoking cessation
measure: Aneuploid sperm count
timeFrame: Up to 12 months after smoking cessation
measure: luteinizing hormone (LH) levels luteinizing hormone (LH) levels luteinizing hormone (LH) levels
timeFrame: Up to 12 months after smoking cessation
measure: Testosterone levels
timeFrame: Up to 12 months after smoking cessation
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse, Service de médecine de la reproduction
Study officials:
affiliation: CHU Toulouse
name: Jessica Moreau, MD
role: PRINCIPAL_INVESTIGATOR
References: