TeratozoospermiaCANNASPERMNCT02932527
Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men
A study testing Questionnaire about cannabis consumption, blood intake and Semen samples collection in people with Teratozoospermia, run by University Hospital, Rouen at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Teratozoospermia
- What is being tested?
- Questionnaire about cannabis consumption, blood intake and Semen samples collection
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Aug 2017to 7 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
France3 sites
Caen University Hospital
Caen
Lille University Hospital
Lille
Rouen University Hospital
Rouen
About this study
Official title: Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men : a Prospective Exposed / Unexposed Study
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.
- Conditions
- Teratozoospermia
- Being tested
- Questionnaire about cannabis consumption, blood intake, Semen samples collection
- Keywords
- cannabis
- Medical subject headings
- Teratozoospermia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire about cannabis consumptionBehavioural
Questionnaire about cannabis consumption will be assessed to infertile male exposed to cannabis and infertile male not exposed to cannabis.
blood intakeProcedure or surgery
blood intake is done for infertile male exposed and infertile male not exposed.
Semen samples collectionProcedure or surgery
Semen samples are collected for infertile male exposed and infertile male not exposed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaire about cannabis consumption; Procedure: blood intake; Procedure: 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. Receives: Behavioral: Questionnaire about cannabis consumption; Procedure: blood intake; Procedure: Semen samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of spermatic aneuploidy rate
Spermatic aneuploidy rate is evaluated for patients exposed and not exposed to cannabis
Measured: Day 1
Secondary outcomes (9)
Evaluation of consumption level
Consumption level are evaluated for patients exposed to cannabis, using questionnaire
Measured: Day 1
Evaluation of cannabinoids level in blood
cannabinoids levels in blood are evaluated for patients exposed and not exposed to cannabis
Measured: Day 1
Total sperm count
Measured: Day 1
Percentage of mobile spermatozoa
Measured: Day 1
Percentage of morphologically abnormal spermatozoa
Measured: Day 1
Mean vacuole area threshold
Mean vacuole area threshold is measured with Receiver Operating Characteristic curves
Measured: Day 1
Correlation coefficient between vacuole areas and sperm DNA fragmentation
Correlation coefficient between vacuole areas and sperm DNA fragmentation are evaluated by TUNEL analysis
Measured: Day 1
Correlation coefficient between vacuole areas and abnormal chromatin condensation
Correlation coefficient between vacuole areas and abnormal chromatin condensation is evaluated by aniline blue staining
Measured: Day 1
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start29 Aug 2017
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TeratozoospermiaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- France VERHAEGHE, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932527
- Sponsor's protocol ID
- 2015/209/HP
- Acronym
- CANNASPERM
- Status last verified
- Feb 2026
- First submitted
- 7 Oct 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men : a Prospective Exposed / Unexposed Study
- ClinicalTrials.gov ID
- NCT02932527
- Acronym / sponsor ID
- CANNASPERM / 2015/209/HP
- Conditions
- Teratozoospermia
- Keywords
- cannabis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infertile men exposed to cannabis | Experimental | Behavioral: Questionnaire about cannabis consumption, Procedure: blood intake, Procedure: Semen samples collectionMale 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. |
| infertile men not exposed to cannabis | Other | Behavioral: Questionnaire about cannabis consumption, Procedure: blood intake, Procedure: Semen samples collectionMale 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire about cannabis consumptionQuestionnaire about cannabis consumption will be assessed to infertile male exposed to cannabis and infertile male not exposed to cannabis. | Behavioural | infertile men exposed to cannabis, infertile men not exposed to cannabis |
| blood intakeblood intake is done for infertile male exposed and infertile male not exposed. | Procedure or surgery | infertile men exposed to cannabis, infertile men not exposed to cannabis |
| Semen samples collectionSemen samples are collected for infertile male exposed and infertile male not exposed. | Procedure or surgery | infertile men exposed to cannabis, infertile men not exposed to cannabis |
Primary outcome
Evaluation of spermatic aneuploidy rate
Time frame: Day 1
Spermatic aneuploidy rate is evaluated for patients exposed and not exposed to cannabis
9 secondary outcomes
Evaluation of consumption level
Time frame: Day 1
Evaluation of cannabinoids level in blood
Time frame: Day 1
Total sperm count
Time frame: Day 1
Percentage of mobile spermatozoa
Time frame: Day 1
Percentage of morphologically abnormal spermatozoa
Time frame: Day 1
Mean vacuole area threshold
Time frame: Day 1
Correlation coefficient between vacuole areas and sperm DNA fragmentation
Time frame: Day 1
Correlation coefficient between vacuole areas and abnormal chromatin condensation
Time frame: Day 1
Correlation coefficient between vacuole areas and telomere number, distribution and length
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
France VERHAEGHE, MD principal investigator
University Hospital, Rouen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire about cannabis consumption, blood intake and Semen samples collection in people with Teratozoospermia, run by University Hospital, Rouen at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of spermatic aneuploidy rate (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.