Tobacco and Sperm Genome: Effects of Smoking Cessation

Male Infertility Clinical Trial

— TABAGERM  

Official title:

Tobacco and Sperm Genome: Effects of Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552081
• Other study ID #: RC31/17/0344
• Status: Completed
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: June 21, 2022

Study information

• Verified date: July 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

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.

Locations

Country	Name	City	State
France	CHU Toulouse, Service de médecine de la reproduction	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 12 months after smoking cessation
Primary	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	Up to 3 months after smoking cessation
Primary	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	Up to 6 months after smoking cessation
Secondary	Rate of 8-OHdG gamete DNA		Up to 12 months after smoking cessation
Secondary	Spermogram exam	Spermogram examination	Up to 12 months after smoking cessation
Secondary	Fragmentation index (DFI) of gamete DNA		Up to 12 months after smoking cessation
Secondary	Aneuploid sperm count		Up to 12 months after smoking cessation
Secondary	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	Up to 12 months after smoking cessation
Secondary	Testosterone levels	Blood samples at day 0 (before weaning), and at 3 months, 6 months, 12 months after smoking cessation	Up to 12 months after smoking cessation