spermatogenic failure
Conditions
Interventions
Group A:Letrozole 2.5mg once daily (qd) + a dietary complex rich in spermidine 2 tablets twice daily (bid)
Group B:Letrozole 2.5mg once daily (qd)
Group C: a dietary complex rich in spermidine 2 tablets twice daily (bid)
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
22 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Subjects must be at least 22 years old and no more than 50 years old; (2) Subjects must have completed at least two semen analyses and satisfy one of the following semen parameter standards: a) Focal Non-Obstructive Azoospermia (NOA): Absence of spermatozoa following semen centrifugation, yet medical history and clinical findings suggest the potential for focal spermatogenesis (YqAZFc deletion or post-pubertal mumps orchitis); b) Severe Oligoasthenospermia: Sperm concentration ranging from 0 to 5×10^6/mL; accompanied by asthenospermia (less than 32% of spermatozoa exhibit progressive motility in semen); c) Cryptozoospermia: No spermatozoa detected in fresh semen sample, but spermatozoa can be visualized upon microscopic examination of the centrifuged sediment; (3) Subjects must provide informed consent to participate in this study and commit to adhering to the treatment protocol, follow-up appointments, and data collection requirements as specified in the study protocol.
Exclusion criteria
Exclusion criteria: (1) Patients with bilateral obstruction of the vas deferens, such as epididymitis leading to epididymal obstruction, congenital absence of the vas deferens, ejaculatory duct obstruction, or those with concomitant spermatogenic failure; (2) Patients with hypothalamic-pituitary-gonadal axis dysfunction, such as hypogonadotropic hypogonadism (reduced FSH, LH), severe thyroid dysfunction, etc.; (3) Patients with uncontrollable urinary and reproductive system infections, tumors; (4) Patients allergic to the drugs used in the study; (5) Patients with severe systemic diseases, such as hypertension, diabetes, liver dysfunction, etc., that cannot be controlled with drug treatment; (6) Female partner is less than 20 years old or more than 42 years old; (7) Female partner is unwilling to provide data or information related to female fertility assessment; (8) Female partner has a positive pregnancy test within 7 days before randomization or self-reports pregnancy; (9) Female partner has infertility; (10) Other conditions deemed unsuitable for inclusion in the study by the researcher.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Semen parameters;Reproductive Hormones;FertiQoL-simplified Chinese;PSQI-simplified Chinese;Pregnancy of the spouse; | — |
Primary
| Measure | Time frame |
|---|---|
| Treatment Efficacy; | — |
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