Non-obstructive Azoospermia.
Conditions
Interventions
Intervention group: Cell therapy.
Sponsors
National Center of Science and Technology Evaluation
Eligibility
Sex/Gender
Male
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 4.6 cm or bilateral absence of vas deferens or surgical history of vasectomy). Hypogonadotropic hypogonadism (LH 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Kazakhstan
Contacts
Public ContactAmin Tamadon
Boushehr University of Medical Sciences
Outcome results
None listed