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

University Hospital, Rouen

Status: Completed

Conditions: Teratozoospermia

Treatments: Behavioral: Questionnaire about cannabis consumption; Procedure: blood intake; Procedure: Semen samples collection

Study type: Interventional

Funder types: Other

Identifiers

NCT02932527

2015/209/HP

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

infertile men exposed to cannabis

Experimental group

Description:

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.

Treatment:

Procedure: Semen samples collection

Procedure: blood intake

Behavioral: Questionnaire about cannabis consumption

infertile men not exposed to cannabis

Other group

Description:

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.

Treatment:

Procedure: Semen samples collection

Procedure: blood intake

Behavioral: Questionnaire about cannabis consumption