NCT02932527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

August 29, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2021

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

October 7, 2016

Last Update Submit

February 4, 2026

Conditions

Teratozoospermia

Keywords

cannabis

Outcome Measures

Primary Outcomes (1)

  • Evaluation of spermatic aneuploidy rate

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

    Day 1

Secondary Outcomes (9)

  • Evaluation of consumption level

    Day 1

  • Evaluation of cannabinoids level in blood

    Day 1

  • Total sperm count

    Day 1

  • Percentage of mobile spermatozoa

    Day 1

  • Percentage of morphologically abnormal spermatozoa

    Day 1

  • +4 more secondary outcomes

Study Arms (2)

infertile men exposed to cannabis

EXPERIMENTAL

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 consumptionProcedure: blood intakeProcedure: Semen samples collection

infertile men not exposed to cannabis

OTHER

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 consumptionProcedure: blood intakeProcedure: Semen samples collection

Interventions

Questionnaire about cannabis consumptionBEHAVIORAL

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

infertile men exposed to cannabisinfertile men not exposed to cannabis
blood intakePROCEDURE

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

infertile men exposed to cannabisinfertile men not exposed to cannabis
Semen samples collectionPROCEDURE

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

infertile men exposed to cannabisinfertile men not exposed to cannabis

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Caen University Hospital

Caen, France

Location

Lille University Hospital

Lille, France

Location

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

TeratozoospermiaMarijuana Abuse

Condition Hierarchy (Ancestors)

Infertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • France VERHAEGHE, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 13, 2016

Study Start

August 29, 2017

Primary Completion

May 7, 2021

Study Completion

May 7, 2021

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)