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IRCT20190519043634N1 IRCT 2019-08-05 National Center of Science and Technology Evaluation Azoospermia Treatment with Mesenchymal Stem Cell Intra-testicular Injection of Autologous Adipose Derived Mesenchymal Stem Cell (ADMSC) in Non-obstructive Azoospermia Patients: Clinical Trial, Phase I, Non-Randomized 2019-12-22 anticipated 10 Complete https://irct.ir/trial/40720 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Non-obstructive Azoospermia. Intervention group: Cell therapy. Yes - There is a plan to make this available What will be shared: all collected de-identified IPD When: starting 6 months after publication To whom: only available for people working in academic institutions Conditions: For use in meta-analysis studies or systematic review articles Where to obtain: Corresponding with the person responsible for scientific inquiries, Dr. Amin Tamadnan: Moalem Square, Parastar Street, Persian Gulf Biotechnology Research Center, amintamaddon@yahoo.com How to obtain: An official letter with the header of the university or research institute by email or fax to the person responsible for scientific inquiries Comments:
public Amin Tamadon
Moalem Square, Parastar Street, Persian Gulf Biotechnology Research Center
Boushehr Iran (Islamic Republic of) 7514763448 +98 77 3332 8724 amintamaddon@yahoo.com Boushehr University of Medical Sciences scientific Amin Tamadon
Moalem Square, Parastar Street, Persian Gulf Biotechnology Research Center
Boushehr Iran (Islamic Republic of) 7514763448 +98 77 3332 8724 amintamaddon@yahoo.com Boushehr University of Medical Sciences Kazakhstan 20-50 years infertile males seeking fertility treatment with confirmed diagnosis of Non-obstructive azoospermia (NOA). Patients with confirmed diagnostic of Non-obstructive azoospermia based on 2 negative spermogram with centrifugation (three months in between). Patients without sperm cells at semen analysis. Body mass index (BMI) lower than 35. Negative testicular sperm extraction (TESE): Failure of detecting spermatozoid TESE. 20 years 50 years Male Treated with drug which could improve sperm count and quality one month before observation, otherwise, they should have an elution for 1 month before the study. Previous surgical history in Testis. Absent or surgical removed testes Infectious genital diseases. Gram-positive bacteria, Chlamydia Trachomatis,Ureaplasma Urealyticum, or Mycoplasma Hominis were detected in their semen. Anatomical abnormalities of the genital tract Patients with grade 2 or 3 varicocele, persistent after cure of the varicocele. Current or history of testicular tumor detected or testicular cancer or history of any other cancer. Obstructive azoospermia (FSH <7.6 IU/mL plus testicle longitudinally axis >4.6 cm or bilateral absence of vas deferens or surgical history of vasectomy). Hypogonadotropic hypogonadism (LH <2 IU/mL and Follicle Stimulating Hormone (FSH) <1 IU/mL). Patient with Klinefelter or karyotype abnormalities Seminal white blood cell concentration more than 10 million per ml Use of chemotherapy, testosterone, or anti-androgen in the last two years. Partner >40 years or female factor infertility associated. Addicted to drug, tobacco, or alcohol. Under treatment of gonadotropin, anabolic steroid, chemotherapeutic drugs, or nonsteroidal anti-inflammatory drugs. Combined with cardiovascular, liver, kidney, or hematopoietic system severe primary disease, or mental disease. Had heat, chemicals, radioactive material, or toxic contact history within a year. Presence of genetic disorders: abnormal karyotypes and Chromosomal aberration (e.g. Y microdeletion, trisomy…. First TESE conducted under hormonal treatment (Clomifene, Tamoxifen, gonadotrophins or anti-aromatase) Receiving a treatment known to alter male fertility (see RCP of the treatment, colchicine, methotrexate and…) in the 6 months before inclusion. Receiving treatment know to modify the gonadotroph axis activity (FSH, TESTO, DHT, HCG…) Persistent bilateral abdominal cryptorchidism or history of cryptorchidism Patient unable to understand the purpose of the trial or refusing to follow treatment and post-treatment instructions Participation to another trial that would interfere with this trial Treatment - Surgery Intervention group: Cell therapy Induction of spermatogenesis. Timepoint: at 2 week, 1, 2, 3, 4, 5 and 6 post injection day. Method of measurement: Hematological, biochemical, Retrieval sperm rate ,Sperm density, Sperm motility, Total serum testosterone level (TH), Number spermatogonia, Number of spermatocytes, Total serum estradiol level, Total serum follicle stimulating hormone level (FSH), Total serum luteinizing hormone level (LH), Inhibin B hormone, Prolactin, sexual function. National Center of Science and Technology Evaluation Approved 2019-05-22 Medical University of Astana Beibitshilik Street 49/A, Nur-Sultan 010000, Kazakhstan Nur-Sultan Astana Kazakhstan