Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men

Teratozoospermia Clinical Trial

— CANNASPERM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02932527
• Other study ID #: 2015/209/HP
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2017
• Est. completion date: August 2020

Study information

• Verified date: May 2018
• Source: University Hospital, Rouen
• Contact: France VERHAEGHE, MD
• Phone: +3323288
• Email: France.Verhaeghe[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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,

Related Conditions & MeSH terms

• Marijuana Abuse
• Teratozoospermia

Intervention

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

Locations

Country	Name	City	State
France	Caen University Hospital	Caen
France	Lille University Hospital	Lille
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of spermatic aneuploidy rate	Spermatic aneuploidy rate is evaluated for patients exposed and not exposed to cannabis	Day 1
Secondary	Evaluation of consumption level	Consumption level are evaluated for patients exposed to cannabis, using questionnaire	Day 1
Secondary	Evaluation of cannabinoids level in blood	cannabinoids levels in blood are evaluated for patients exposed and not exposed to cannabis	Day 1
Secondary	Total sperm count		Day 1
Secondary	Percentage of mobile spermatozoa		Day 1
Secondary	Percentage of morphologically abnormal spermatozoa		Day 1
Secondary	Mean vacuole area threshold	Mean vacuole area threshold is measured with Receiver Operating Characteristic curves	Day 1
Secondary	Correlation coefficient between vacuole areas and sperm DNA fragmentation	Correlation coefficient between vacuole areas and sperm DNA fragmentation are evaluated by TUNEL analysis	Day 1
Secondary	Correlation coefficient between vacuole areas and abnormal chromatin condensation	Correlation coefficient between vacuole areas and abnormal chromatin condensation is evaluated by aniline blue staining	Day 1
Secondary	Correlation coefficient between vacuole areas and telomere number, distribution and length	Correlation coefficient between vacuole areas and telomere number, distribution and length is evaluated by quantitative FISH	Day 1