Clinical trial: Fresh Vs Frozen Surgical Sperm in IVF (NCT03361982)

Eligibility criteria:
Inclusion Criteria:

          -  Females age < 42 with an indication for IVF

          -  Females with lowest AMH level 1.2 ng/mL or higher

          -  Females with FSH < 13 mIU/mL

          -  Sperm obtained via Surgical retrieval (any type) for IVF only

          -  Use of comprehensive chromosome screening (CCS) to screen embryos for aneuploidy

          -  BMI < 35

          -  Baseline antral follicle count of > 8

          -  Single embryo transfers only

        Exclusion Criteria:

          -  Anything that would place the individual at increased risk or preclude the
             individual's full compliance with or completion of the study.

          -  Contraindication to IVF

          -  Clinical indication for preimplantation genetic diagnosis (PGD) (i.e., screening for
             single gene disorder, chromosomal translocation, or any other disorders requiring
             detailed embryo genetic analysis)

          -  Fewer than 4 mature oocytes retrieved (will not randomize)

          -  Male partner with non-obstructive azoospermia

          -  Male partner with any Karyotype other than 46,XY

          -  Male partner with history of spinal cord injury

          -  Male partner with Kallman's syndrome

          -  History of chronic oligomenorrhea

          -  History of hydrosalpinges or adnexal mass

          -  History of endometrial insufficiency (max endometrial thickness < 7mm)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



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