Clinical trial: Diet and Its Relationship With Couple Infertility (NCT01093378)

Eligibility criteria:
Inclusion Criteria:

        Common to both infertile and fertile couples:

          -  Couples where both members are over eighteen and at childbearing age (≤38 for women
             and ≤ 45 for men)

          -  Couples where both members agreed to take part in the study

          -  Couples where both members completed a medical check-up and gave an informed consent.
             Infertile couples could be included following a medical consultation for infertility

          -  Couples with none of its member facing any comprehension difficulty in oral or written
             French language

          -  Couples where both members are affiliated to the French NHS [national health service]
             (beneficiary or legal claimant)

        Specific to fertile couples:

        - fertile couples who naturally and spontaneously conceived a or many children with a time
        to conceive shorter than 12 months.

        Specific to infertile couples:

          -  Infertile couples (primary, infertility, inability to conceive a child after 12 months
             of unprotected sexual intercourse)

          -  Couples where the male partner has sperm parameters compatible with a natural
             conception

          -  Couples where the female partner does not present anovulation, ovarian insufficiency
             and or any uterus-tubal pathology

        Exclusion Criteria:

        Common to both infertile and fertile couples:

          -  couples where one of the members is under eighteen or not a childbearing age (>38 for
             women an >45 for men)

          -  couples where at least one member refused to give written agreement for the study

          -  couples where at least one member shows any known cardiovascular risk (diabetes,
             hypercholesterolemia, HBR)

          -  couples where at least one member shows any known cardiovascular pathology, digestive
             pathology, no good absorptive pathology or a cancer

          -  couples where at least one member faces some difficulty in understanding French
             language

          -  couples where at least one member is not affiliated with the French NHS (beneficiary
             or legal claimant)

        Specific to fertile couples:

        •Couples where the woman had a miscarriage or medical termination of pregnancy with current
        partner

        Specific to infertile couples:

          -  Couples in which it is not the first pregnancy

          -  Couples with the male member showing either:

               -  severe oligozoospermia (<5 millions/ml) or a confirmed azoospermia (absence of
                  spermatozoid in the ejaculate)

               -  a moderate non idiopathic oligozoospermia (5-20 millions/ml), related to one more
                  of the following factors:

                    1. toxic (chemotherapy, radiotherapy, drugs with a demonstrated effect on
                       spermatogenesis)

                    2. infectious

                    3. anatomic: vasectomy, congenital anomaly (agenesis of vas deferens), long
                       post-traumatic ischemia

                    4. endocrine: hypogonadotropic, hypogonadism

                    5. cytogenetic: klinefelter syndrome, translocation

          -  couples whose male partner shows an abnormality of the male genital tractus :
             VARICOCEME undescended,testis, testicular volume < 12ml

          -  couples whose female partner presents an anovulation, ovarian insufficiency or a
             proven uterus-tubal pathology
No condition on gender to be admitted to the trial.
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