Evaluation of Safety and Efficacy of Secretome in Non-Obstructive Azoospermia Patients

Phase 1

• Conditions: on-obstructive azoospermia.; Azoospermia; N46.0

• Registration Number: IRCT20221026056311N1
• Lead Sponsor: Iranian academic center for education culture and research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 20

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.