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

Primary Purpose

Male Infertility

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fragmented DNA evaluation in blood and semen samples
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Male Infertility focused on measuring spermatogenesis, tobacco, DNA Fragmentation Index

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • CHU Toulouse, Service de médecine de la reproduction

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fragmented DNA evaluation in blood and semen samples

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Rate of 8-OHdG gamete DNA
Spermogram exam
Spermogram examination
Fragmentation index (DFI) of gamete DNA
Aneuploid sperm count
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
Testosterone levels
Blood samples at day 0 (before weaning), and at 3 months, 6 months, 12 months after smoking cessation

Full Information

First Posted
April 25, 2018
Last Updated
July 18, 2022
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03552081
Brief Title
Tobacco and Sperm Genome: Effects of Smoking Cessation
Acronym
TABAGERM
Official Title
Tobacco and Sperm Genome: Effects of Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
spermatogenesis, tobacco, DNA Fragmentation Index

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fragmented DNA evaluation in blood and semen samples
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Fragmented DNA evaluation in blood and semen samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 12 months after smoking cessation
Description
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
Title
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 3 months after smoking cessation
Description
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
Title
Change of the Percentage of spermatozoa presenting a fragmented DNA from Baseline to 6 months after smoking cessation
Description
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
Secondary Outcome Measure Information:
Title
Rate of 8-OHdG gamete DNA
Time Frame
Up to 12 months after smoking cessation
Title
Spermogram exam
Description
Spermogram examination
Time Frame
Up to 12 months after smoking cessation
Title
Fragmentation index (DFI) of gamete DNA
Time Frame
Up to 12 months after smoking cessation
Title
Aneuploid sperm count
Time Frame
Up to 12 months after smoking cessation
Title
luteinizing hormone (LH) levels luteinizing hormone (LH) levels luteinizing hormone (LH) levels
Description
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
Title
Testosterone levels
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Moreau, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse, Service de médecine de la reproduction
City
Toulouse
Country
France

12. IPD Sharing Statement

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Tobacco and Sperm Genome: Effects of Smoking Cessation

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