Non-obstructive azoospermia. Azoospermia
Conditions
Interventions
Intervention group: Intra-testicular injection of human menstrual blood stem cells secretome. Under local anesthesia with 2% lidocaine (7mg/kg), the scrotum will be cleaned with normal saline solution
Sponsors
Iranian academic center for education culture and research
Eligibility
Sex/Gender
Male
Age
25 Years to 45 Years
Inclusion criteria
Inclusion criteria: Age 25-45 years old BMI less than 35 Idiopathic non-obstructive azoospermia (maturation arrest) Consent to TESE Negative sperm test (2 test within 4 weeks) FSH level more than 7.6 IU/L Testes longitudinal axis less than 4.5 cm At least 1 year since diagnosis Testes volume less than 12 cc Non-atrophic testes (confirm by ultrasound) Normal karyotype No intake of drug and hormonal medicine at least in the last 6 months Negative sperm analysis
Exclusion criteria
Exclusion criteria: Patients older than 25 years old and under 45 years old History of heart/brain stroke in the past year Anemia or any other hematological disorders History of pelvic trauma Obstructive azoospermia Patients with hypogonadotropic hypogonadism (HH) non-obstructive azoospermia (LH lower than 2IU/mL and FSH lower than 1 lU/mL) Hormonal drugs and/or gonadotoxic drugs intake in the last 6 months Infectious disease of genital system History of testes surgery, biopsy of the testes and anatomical abnormality of genital system History of alcohol and drug abuse Tyroeid dysfunction Immunu system diseases History of cancer, chemotherapy or radiotherapy Infected with Hepatitis B,C and HIV Diabetic Hepatic abnormality Cryptozoospermia Varicocele Hyperprolactinemia Chromosal disorder Systemic disorders Infertility factors in the sexual partner Sexual partner over 40 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute side effects. Timepoint: 24 hours, 72 hours, 1 week after each administration. Method of measurement: Clinical observation any signs of pain, allergy reaction, hemorrhage.;Spermatogenesis induction. Timepoint: 3, 6 month and 1 year after the last adminstartion. Method of measurement: Sperm analysis, hematology, biochemistry, serum testosterone level, total serum follicle stimulating hormone (FSH), serum luteinizing hormone (LH) level, sexual function, measurement of the longitudinal axis of the testes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Spontaneous pregnancy. Timepoint: 6 month and 1 year after the last injection. Method of measurement: Clinical observation.;Clinical pregnancy. Timepoint: 6 months and 1 year after the last injection. Method of measurement: Clinical approach for pregnancy- clinical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Naser Amir Jannati
Iranian academic center for education culture and research
Outcome results
None listed