Clinical trial: Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement (NCT03475199)

Eligibility criteria:
Inclusion Criteria:

          -  All male volunteers aged 18 to 45 years belonging to a couple reporting an involuntary
             infertility greater than 12 months

          -  Conventional spermatic parameters compatible with spontaneous pregnancy

               -  Sperm Count> 5M / ml and

               -  Progressive sperm mobility> 20%

          -  Negative spermoculture

          -  Fragmentation of sperm DNA> 20%

          -  Patient able to understand dietary recommendations given in French, in writing and
             orally

          -  Social insured patient receiving benefits from the French Social Security health
             branch

          -  Patient with a mobile phone (iOS or Android) with internet access

        Exclusion Criteria:

          -  Patient diagnosed with severe oligospermia (<5 million spz / ejaculate)

          -  Patient with BMI> 35 or <18.5

          -  Patient with known and treated diabetes

          -  Patient with known and treated lipid disorders

          -  Patient with known and treated cardiovascular diseases

          -  Patients with known and treated hypertension

          -  Patients with known and treated dysthyroidism

          -  Patients with known symptomatic varicocele

          -  Patient with known inflammatory bowel diseases

          -  Patient with renal failure diagnosed

          -  Patient presenting a viral risk (HIV / Hepatitis B and C / ...) requiring support in a
             dedicated circuit

          -  Patient unable to give informed consent

          -  Minors and protected adults, vulnerable people

          -  Patient participating in another clinical research study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 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