Clinical trial: Effect of Cannabis Consumption on Sperm Nuclear Quality in Infertile Men (NCT02932527)

Eligibility criteria:
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,
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction