Condition 1: Non-obstructive Azoospermia. Condition 2: Cryptozoospermia. Azoospermia
Conditions
Interventions
Intervention 1: Intervention group 1: Men with non-obstructive azoospermia. Type of intervention: Intratesticular injection of Wharton's jelly MSC-derived exosomes. Dose: 2 intratesticular injections
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 to 45 years Proof of cryptozoospermia and non-obstructive azoospermia in at least 2 previous semen analyses (with an interval of 15 days) Diagnosis of cryptozoospermia and non-obstructive azoospermia (hormonal evaluation) BMI less than 35 Idiopathic NOA FSH more than 7.6 IU/ML Total testicular length less than 4.5 cm one year before diagnosis Testicular volume less than 12 cc Non-atrophic testicle (proven by ultrasound) Normal karyotype
Exclusion criteria
Exclusion criteria: Patients with NOA due to hypogonadotropic hypogonadism Receiving hormones and gonadotoxic drugs in the past 6 months History of stroke/heart attack in the past year Anemia and any other hematological disorder History of pelvic trauma Patients with NOA with LH less than 2IU/ml and FSH less than 1IU/ml Infectious diseases of the genital system History of testicular surgery Testicular biopsy and anatomical disorders of the genital system History of alcohol and drug use Thyroid disorders Immune system diseases Genetic abnormalities in the genital tract History of cancer and chemotherapy and radiotherapy Hepatitis B and C and AIDS Diabetic liver disorder Varicocele Hyperprolactinemia Spouse over 40 years old Patients with systemic medical problems Patients with chromosomal disorders Infertile spouse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of inflammation and infection. Timepoint: Assessment at 24 hours, 72 hours, and one week after each injection. Method of measurement: Checking the amount of activated protein C and the erythrocyte sedimentation rate in a blood sample.;Incidence and severity of immune reaction. Timepoint: Assessment at 24 hours, 72 hours, and one week after each injection. Method of measurement: Checking the amount of immunoglobulin E and performing the complete blood count test.;Sperm retrival. Timepoint: Before the start of the study and 3 months and 6 months after the last injection. Method of measurement: Performing the sperm analysis test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum testosterone level. Timepoint: Before intervention, 3 months, and 6 months after the last injection. Method of measurement: Quantitative measurement using Enzyme-Linked Immunosorbent Assay (ELISA) from peripheral blood samples.;Serum Luteinizing Hormone (LH) Level. Timepoint: Before intervention, 3 months, and 6 months after the last injection. Method of measurement: Quantitative measurement using Enzyme-Linked Immunosorbent Assay (ELISA) from peripheral blood samples.;Serum Follicle-Stimulating Hormone (FSH) Level. Timepoint: Before intervention, 3 months, and 6 months after the last injection. Method of measurement: Quantitative measurement using Enzyme-Linked Immunosorbent Assay (ELISA) from peripheral blood samples.;Sperm Parameters (Count, Motility, Morphology). Timepoint: Before intervention, 3 months, and 6 months after the last injection. Method of measurement: Semen analysis according to WHO Laboratory Manual standards, performed by two independent andrologists.;Fertilization Rate. Timepoint: 24 hours after Intracytoplasmic Sperm Injection (ICSI) procedure. Method of measurement: Percentage of fertilized oocytes (2PN) per injected oocytes under inverted microscopy.;Biochemical Pregnancy. Timepoint: 2–3 weeks after embryo transfer. Method of measurement: Detection of serum ß-hCG confirming biochemical pregnancy.;Clinical Pregnancy. Timepoint: 3–5 weeks after embryo transfer. Method of measurement: Confirmation by transvaginal ultrasound showing gestational sac and fetal heartbeat. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzar Sheikholeslami
Iranian academic center for education culture and research
Outcome results
None listed