Clinical trial: Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH (NCT02307994)

Eligibility criteria:
Inclusion Criteria:

          -  Male subjects aged 20~35.

          -  They accorded with diagnostic criteria of severe oligospermia or azoospermia.

          -  They had'nt been treated with drug which could improve sperm count and quality one
             month before observation，otherwise,they should have a elution for 1 month before the
             study.

        Exclusion Criteria:

          -  Gram-positive bacteria ,Chlamydia trachomatis,Ureaplasmaurealyticum,or mycoplasma
             hominis were detected in their semen.

          -  Subjects addicted to drug，tobacco，or alcohol.

          -  Subjects had heat,chemicals,radioactive material,or toxic contact history within a
             year.

          -  Subjects were under treatment of gonadotropin,anabolic steroid,chemotherapeutic
             drugs,or nonsteroidal anti-inflammatory drugs .

          -  Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe
             primary disease,or mental disease.

          -  Subjects were allergic or on uFSH allergy,or under the treatment of other drugs for
             infertility .

          -  Subjects did not meet the inclusion criteria, did not according to the prescribed
             medication, were unable to judge the efficacy ,had incomplete information, or affected
             the efficacy or safety judgment.

          -  Subjects were IHH patients
Male
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 35 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? Entailment