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Completed

NCT Number: NCT02932527

Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Questionnaire about cannabis consumption

Behavioral

Questionnaire about cannabis consumption will be assessed to infertile male exposed to cannabis and infertile male not exposed to cannabis.

blood intake

Procedure

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

Semen samples collection

Procedure

Semen samples are collected for infertile male exposed and infertile male not exposed.

Primary outcomes

  1. Evaluation of spermatic aneuploidy rate

    Time frame: Day 1

    Spermatic aneuploidy rate is evaluated for patients exposed and not exposed to cannabis

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men : a Prospective Exposed / Unexposed Study

Acronym: CANNASPERM

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 13, 2016
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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