Clinical trial: Folic Acid and Zinc Supplementation Trial (FAZST) (NCT01857310)

Eligibility criteria:
Couples Inclusion Criteria:

          1. Heterosexual couples in a committed relationship with a female partner aged 18-45
             years and male partner aged 18 years and older attempting to conceive and seeking
             assisted reproduction at participating fertility clinics.

          2. Couples actively trying to conceive.

          3. Couples who are planning ovulation induction (OI), natural fertility optimization
             methods, or intrauterine insemination (IUI) should be willing to be on the study
             dietary supplement for at least 3 weeks before starting the next assisted reproduction
             cycle.Women with regular periods may initiate their fertility therapy at the start of
             the woman's menstrual cycle following randomization if randomization occurred within
             the first 10 days of the cycle, but must wait one menstrual cycle if the visit
             occurred after day 10 of the cycle). For women with irregular periods or amenorrhea,
             the male must be on the study supplement for 3 weeks prior to initiation of any
             ovulation induction medication (e.g., clomid, letrozole, gonadotropins).

        Couples Exclusion Criteria:

          1. Female partner unwilling to participate (e.g., no abstraction of her assisted
             fertility treatment record or unwilling to complete baseline visit).

          2. Couples using donor, cryopreserved sperm, or sperm obtained via microsurgical or
             percutaneous epididymal sperm aspiration.

          3. Couples attempting to conceive with a gestational carrier (surrogate).

          4. Positive urine pregnancy test at screening.

        Male Inclusion Criteria:

          1. Willing to provide semen samples according to the proposed schedule at baseline, 2, 4,
             and 6 months of follow-up.

          2. Able to complete regular study questionnaires and daily journals aimed at capturing
             ejaculation, sexual intercourse and lifestyle factors considered to affect male
             fecundity (e.g., cigarette smoking, fever, high temperature environment and other
             environmental exposures) and other data collection instruments (e.g., physical
             activity, food frequency questionnaire, stress).

        Male Exclusion Criteria:

          1. Age <18 years.

          2. Unwilling to abstain from use of non-study approved dietary supplements or medications
             containing folic acid or oral preparations containing zinc throughout the study.

          3. Unwilling to abstain from use of testosterone supplementation throughout the study.

          4. Diagnosis of Vitamin B12 deficiency or pernicious anemia.

          5. Consuming a vegan diet.

          6. A known genetic cause of male factor subfertility, including chromosomal disorders
             related to subfertility (e.g., Y chromosome deletions).

          7. Males currently using and unwilling (or unable) to discontinue the following drugs
             known to interact with folic acid or interfere with the biosynthesis of folic acid
             will be excluded.

               1. Dihydrofolate reductase inhibitors: Trimethoprim, Triamterene, Bactrim, Iclaprim

               2. Sulfonamides: Hydrochlorothiazide (HCTZ), Metolazone, Indapamide, Lasix, Bumex,
                  Torsemide, Chlorthalidone, Acetazolamide, Mefruside, Xipamide

               3. Sulfonylureas: Glipizide, Glyburide

               4. Cox-2 inhibitors: Celecoxib

               5. Others: Valproic acid, Probenecid, Sulfasalazine, Sumatriptan, Mafenide,
                  Ethoxzolamide, Sulfiram, Zonisamide, Dorzolamide (optic), Dichlorphenamide,
                  Fluorouracil, Capecitabine, Methotrexate

          8. History of organ transplantation.

          9. Physician diagnosed:

               1. Current poorly controlled chronic diseases such as heart disease, diabetes
                  mellitus, hypertension, cancer, inflammatory diseases, autoimmune, thyroid
                  disease, endocrine dysfunction, liver disease, kidney disease, or HIV/AIDS or
                  other immune-insufficient related illnesses.

               2. Crohn's disease, celiac disease, ulcerative colitis, gastric bypass surgery, lap
                  band surgery or history of intestinal surgery to remove a portion of small bowel.
                  History of diseases/symptoms that require folic acid dietary supplementation,
                  such as megaloblastic anemia, homocystinemia, and homocystinuria.

               3. History of alcohol dependency disorder and/or other drug/substance dependency in
                  the past 180 days.

               4. History of psychoses or other mental conditions that would result in cognitive
                  impairment and inability to participate in any part of this study including the
                  informed consent process, as diagnosed by a physician within the past year.

         10. History of vasectomy without reversal, obstructive azoospermia such as Congenital
             Bilateral Aplasia of Vas Deferens (CBAVD), or ejaculatory duct obstruction.

         11. Known allergy to folic acid or zinc dietary supplements.

        Female Exclusion Criteria:

        Age <18 or >45 years.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
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