spermatogenic failure
Conditions
Interventions
Experimental group:Letrozole 2.5mg, oral administration, once daily
Vitamin C 100mg, oral administration, once daily
Vitamin E 100mg, oral administration, once daily.
Control group:Vitamin C 100mg, oral administration, once daily
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
22 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Age 22-50 years. 2. Participants who have undergone at least 2 semen analysis examinations and meet one of the following semen parameter criteria: (1) Azoospermia: Confirmed absence of sperm after semen centrifugation; (2) Severe Oligozoospermia: Sperm concentration between 0 and 5×10^6/mL (3) Cryptozoospermia: Fresh semen samples show no sperm, but sperm can be observed in centrifuged sediment under a microscope; 3. Participants must express willingness to participate in the study and adhere to the treatment regimen, follow-up, and data collection as per the research protocol.
Exclusion criteria
Exclusion criteria: 1. Participants with bilateral obstructive factors in the reproductive tract, including epididymal obstruction due to epididymitis, congenital absence of vas deferens, ejaculatory duct obstruction, or those with concomitant spermatogenic failure, as well as patients with abnormal CFTR testing; 2. Participants diagnosed with hypogonadotropic hypogonadism, including idiopathic hypogonadotropic hypogonadism (characterized by reduced FSH, LH), or severe thyroid dysfunction; 3. Participants exhibiting spermatogenic disorders due to the complete deletion of AZFa, AZFb, AZFb+c, and AZFa+b+c regions on the long arm of the Y chromosome; 4. Participants with verified genetic factors contributing to spermatogenic arrest, including chromosomal abnormalities, pathogenic gene variations, CNV deletions, and other relevant genetic factors; 5. Participants experiencing unmanageable genitourinary infections or malignancies; 6. Participants with a history of drug allergies to the investigational medications; 7. Participants with severe systemic diseases, such as unmanageable hypertension, diabetes, or liver dysfunction despite receiving medical treatment; 8. Participants who have previously received systemic treatment with aromatase inhibitors or microdissection testicular sperm extraction (mTESE); 9. Female partners aged 42 years; 10. Female partners unwilling to provide essential data or information for female fertility assessment; 11. Female partners with a positive pregnancy test within the last 7 days or self-reported pregnancy; 12. Additional reasons considered ineligible for study inclusion by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHO-SCC upgrade rate (WHO Sperm concentration category upgrade rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Total sperm number;Concentration of spermatozoa;Total motile sperm count;Semen volume;Total testosterone;Follicle stimulating hormone;Luteinizing hormone;Prolactin;Estradiol;Albumin;Sex hormone-binding globulin;Cumulative pregnancy outcomes in female partners of the participants;NVOG-TMSCC (NVOG total motile sperm count category) upgrade rate;WHO-SCC (WHO Sperm Concentration Category);Testosterone/estradiol ratio; | — |
Countries
China
Contacts
Public ContactZheng Li
Department of Andrology, the Center for Men’s Health, Urologic Medical Center, Shanghai General Hospital
Outcome results
None listed