Informations générales (source: ClinicalTrials.gov)
Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men : a Prospective Exposed / Unexposed Study (CANNASPERM)
Interventional
N/A
University Hospital, Rouen (Voir sur ClinicalTrials)
août 2017
août 2020
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Caen University Hospital - Caen - France | Emeline BOVET-COURTOIS, MD | Contact (sur clinicalTrials) | |||
| Lille University Hospital - Lille - France | Anne-Laure BARBOTIN, MD | Contact (sur clinicalTrials) | |||
| Rouen University Hospital - Rouen - France | France VERHAEGHE, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
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,
- 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,
- 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,