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Tobacco and Sperm Genome: Effects of Smoking Cessation (TABAGERM)

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ClinicalTrials.gov Identifier: NCT03552081
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.

Condition or disease Intervention/treatment Phase
Male Infertility Other: Fragmented DNA evaluation in blood and semen samples Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tobacco and Sperm Genome: Effects of Smoking Cessation
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: fragmented DNA evaluation in blood and semen samples
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Rate of 8-OHdG gamete DNA [ Time Frame: Up to 12 months after smoking cessation ]
  2. Spermogram exam [ Time Frame: Up to 12 months after smoking cessation ]
    Spermogram examination

  3. Fragmentation index (DFI) of gamete DNA [ Time Frame: Up to 12 months after smoking cessation ]
  4. Aneuploid sperm count [ Time Frame: Up to 12 months after smoking cessation ]
  5. luteinizing hormone (LH) levels luteinizing hormone (LH) levels luteinizing hormone (LH) levels [ Time Frame: Up to 12 months after smoking cessation ]
    Blood samples at day 0 (before weaning), and at 3 months, 6 months, 12 months after smoking cessation

  6. Testosterone levels [ Time Frame: Up to 12 months after smoking cessation ]
    Blood samples at day 0 (before weaning), and at 3 months, 6 months, 12 months after smoking cessation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552081


Contacts
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Contact: Jessica Moreau, MD 05 67 77 10 17 moreau.j@chu-toulouse.fr

Locations
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France
CHU Toulouse, Service de médecine de la reproduction Recruiting
Toulouse, France
Contact: Jessica Moreau, MD       moreau.j@chu-toulouse.fr   
Principal Investigator: Jessica Moreau, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Jessica Moreau, MD CHU Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03552081     History of Changes
Other Study ID Numbers: RC31/17/0344
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
spermatogenesis
tobacco
DNA Fragmentation Index
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female