The Effects of Intratesticular PRP Injection in Men With Azoospermia or Cryptozoospermia
Condition: Azoospermia, Nonobstructive
MeSH terms: Azoospermia
Study type: Interventional

Summary: 
      The study will be conducted in men with a diagnosis of non-obstructive azoospermia or
      cryptozoospermia after obtaining written informed consent. The diagnosis of azoospermia and
      cryptozoospermia will be based on two semen analyses performed at least 15 days apart,
      followed by a documented micro testicular sperm extraction (TESE). A detailed history will be
      obtained, physical examination and laboratory evaluation will be performed prior to
      treatment. In physical examination, testicular volumes will be evaluated using an
      orchiometer. Serum FSH and testosterone values will be determined. PRP will be prepared by
      centrifugation of approximately 20 ml autologous blood obtained by phlebotomy. PRP (3 ml)
      will be administered into the seminiferous tubule or interstitial space of each testis. Sperm
      analysis, testicular volume (using orchiometer), serum FSH and testosterone levels will be
      reevaluated at 8 weeks post-procedure. Micro TESE will performed on the third month after PRP
      procedure.
    

Detailed description: 
      Platelet-rich plasma (PRP) is a unique autologous agent derived from blood that is rich in
      growth factors, cytokines, and hormones; it has been reported to reduce oxidative stress and
      reactive oxygen species generation and upregulate the expression of various antioxidant
      enzymes. PRP is used in a variety of clinical applications in cell therapy. Based on World
      Health Organization guidelines, azoospermia is diagnosed when the absence of sperm is
      observed in two semen samples. Based on World Health Organization (WHO), cryptozoospermia is
      diagnosed when spermatozoa cannot be observed in a fresh semen sample; however, it is found
      after an extended centrifugation and microscopic search. All patients require a clinical
      work-up with physical examination, endocrine evaluation (follicle stimulating hormone (FSH),
      luteinizing hormone (LH) and testosterone) and genetic analysis. Scrotal and transrectal
      ultrasounds will be performed as indicated. Platelet-rich plasma (PRP), with its rich growth
      factor composition, has proven beneficial in regenerative therapy. The potential therapeutic
      role of PRP has not been studied in testis for non-obstructive azoospermia and
      cryptozoospermia. The investigators will investigate sperm parameters in non-obstructive
      azoospermic and crypotozoospermic patients treated with PRP.
    

Intervention name(s): PRP injection into at least one testis
Intervention type(s): Biological
Intervention description(s): Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under local anesthesia. Sperm analysis, testicular volumes (using orchiometer), serum FSH and testosterone measurements will be re-evaluated at 8 weeks post-procedure. On the third month after the procedure, presence of spermatozoa will be reassessed in micro testicular sperm extraction (TESE) material.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment