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Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men (CANNASPERM)

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ClinicalTrials.gov Identifier: NCT02932527
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
Lifestyle and environmental factors can disrupt development and testicular function. In France, cannabis is the most widely used illicit substance and about 8% of adults between 18 and 64 years smoke cannabis at least once a year, and mostly men under 45 years. Endocannabinoids are lipid mediators that share some effects with the active ingredients of cannabis. Cannabis and endocannabinoids act via two types of endogenous receptors which were detected at different levels of the reproductive system and are involved in the central and local regulation of the gonad. Cannabis use may alter the normal regulation of the endocannabinoid system. In males, the regulation of the endocannabinoid system is critical for Sertoli and Leydig cells functions, germ cell differentiation, maturation of sperm nucleus and sperm quality. The cannabis can have a negative impact on sperm parameters, capacitation and acrosome reaction. Cannabinoids may decrease testosterone synthesis and induce apoptosis of Sertoli cells. Studies on the effect of cannabinoids on male fertility are scarce or nonexistent in infertile men because of ethical considerations and bias due to consumption often underreported. Investigators hypothesized that cannabis use may alter sperm nuclear quality. Investigators want to explore this hypothesis conducting a multicentric prospective study exposed/non-exposed in infertile men who are consulting for Medically Assisted Reproductive Technologies (ART). To reach this study, it is planned to include a total of 200 subjects taking into account any exclusions.

Condition or disease Intervention/treatment Phase
Teratozoospermia Behavioral: Questionnaire about cannabis consumption Procedure: blood intake Procedure: Semen samples collection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men : a Prospective Exposed / Unexposed Study
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: infertile men exposed to cannabis
Male with isolated teratozoospermia or associated with asthenozoospermia and / or oligozoospermia and / or necrozoospermia defined according to WHO recommendations (WHO guidelines, 2010) and the David amended classification (Auger et al., 2001) with normal constitutional karyotype (46, XY) exposed to cannabis; The exposure to cannabis is not an intervention in the study but is a pre-condition for inclusion. Blood intake and semen samples collection are done. Questionnaire about cannabis consumption are assessed to patient.
Behavioral: Questionnaire about cannabis consumption
Questionnaire about cannabis consumption will be assessed to infertile male exposed to cannabis and infertile male not exposed to cannabis.

Procedure: blood intake
blood intake is done for infertile male exposed and infertile male not exposed.

Procedure: Semen samples collection
Semen samples are collected for infertile male exposed and infertile male not exposed.

infertile men not exposed to cannabis
Male with isolated teratozoospermia or associated with asthenozoospermia and / or oligozoospermia and / or necrozoospermia defined according to WHO recommendations (WHO guidelines, 2010) and the David amended classification (Auger et al., 2001) with normal constitutional karyotype (46, XY) not exposed to cannabis; The exposure to cannabis is not an intervention in the study but is a pre-condition for inclusion. Blood intake and semen samples collection are done. Questionnaire about cannabis consumption are assessed to patient.
Behavioral: Questionnaire about cannabis consumption
Questionnaire about cannabis consumption will be assessed to infertile male exposed to cannabis and infertile male not exposed to cannabis.

Procedure: blood intake
blood intake is done for infertile male exposed and infertile male not exposed.

Procedure: Semen samples collection
Semen samples are collected for infertile male exposed and infertile male not exposed.




Primary Outcome Measures :
  1. Evaluation of spermatic aneuploidy rate [ Time Frame: Day 1 ]
    Spermatic aneuploidy rate is evaluated for patients exposed and not exposed to cannabis


Secondary Outcome Measures :
  1. Evaluation of consumption level [ Time Frame: Day 1 ]
    Consumption level are evaluated for patients exposed to cannabis, using questionnaire

  2. Evaluation of cannabinoids level in blood [ Time Frame: Day 1 ]
    cannabinoids levels in blood are evaluated for patients exposed and not exposed to cannabis

  3. Total sperm count [ Time Frame: Day 1 ]
  4. Percentage of mobile spermatozoa [ Time Frame: Day 1 ]
  5. Percentage of morphologically abnormal spermatozoa [ Time Frame: Day 1 ]
  6. Mean vacuole area threshold [ Time Frame: Day 1 ]
    Mean vacuole area threshold is measured with Receiver Operating Characteristic curves

  7. Correlation coefficient between vacuole areas and sperm DNA fragmentation [ Time Frame: Day 1 ]
    Correlation coefficient between vacuole areas and sperm DNA fragmentation are evaluated by TUNEL analysis

  8. Correlation coefficient between vacuole areas and abnormal chromatin condensation [ Time Frame: Day 1 ]
    Correlation coefficient between vacuole areas and abnormal chromatin condensation is evaluated by aniline blue staining

  9. Correlation coefficient between vacuole areas and telomere number, distribution and length [ Time Frame: Day 1 ]
    Correlation coefficient between vacuole areas and telomere number, distribution and length is evaluated by quantitative FISH



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male Patient,
  • Patient age ≥ 18 years,
  • Infertile patient with isolated teratozoospermia or associated with asthenozoospermia and / or oligozoospermia and / or necrozoospermia, defined according to WHO recommendations (WHO guidelines, 2010) and the David amended classification (Auger et al, 2001) for teratozoospermia
  • Patient with normal constitutional karyotype (46, XY).
  • Smoking tobacco,
  • Drinking ≤ 20 g (2 units) / day,
  • Patient exposed : Cannabis user for over 3 months and consuming at least weekly (≥ 1 / week) [questionnaire and positive blood detection of Delta-9-Tetrahydrocannabinol (THC) and / or its derivatives (11-hydroxy-THC and 11-nor-9-carboxy-THC)].
  • Unexposed : No cannabis user (questionnaire and negative blood detection of Delta-9-THC and its derivatives) matched for age (+/- 2.5 years) with exposed patients included,

Exclusion Criteria:

  • Patient age > 60 years
  • Patient with azoospermia
  • Patient previously exposed to gonadotoxic treatment (chemotherapy, radiotherapy, androgen therapy and other gonadotoxic treatments),
  • Patient with professional toxic exposure,
  • Patient consuming other recreational drugs,
  • Patient with severely impaired sperm parameters and sperm counts <1 million,

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): NCT02932527


Contacts
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Contact: France VERHAEGHE, MD +3323288 ext 8990 France.Verhaeghe@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
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France
Caen University Hospital Recruiting
Caen, France
Contact: Emeline BOVET-COURTOIS, MD         
Principal Investigator: Emeline BOVET-COURTOIS, MD         
Lille University Hospital Recruiting
Lille, France
Contact: Anne-Laure BARBOTIN, MD         
Principal Investigator: Anne-Laure BARBOTIN, MD         
Rouen University Hospital Recruiting
Rouen, France
Contact: France VERHAEGHE, MD       France.Verhaeghe@chu-rouen.fr   
Principal Investigator: France VERHAEGHE, MD         
Sub-Investigator: Nathalie RIVES, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: France VERHAEGHE, MD Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02932527     History of Changes
Other Study ID Numbers: 2015/209/HP
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Rouen:
cannabis
Additional relevant MeSH terms:
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Teratozoospermia
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Infertility
Genital Diseases, Male
Infertility, Male