Varicocele-associated heat stress male infertility disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for varicocele according to Western medicine; (2) Meets the diagnostic criteria for kidney deficiency and blood stasis syndrome according to Traditional Chinese Medicine (TCM); (3) Sperm concentration: 1×10^6/ml = sperm concentration <15×10^6/ml or 1% = PR <32%; (4) Patient age: 18 years = age =60 years; (5) Voluntarily participates in this clinical trial and signs the written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Congenital obstructive azoospermia, genital malformations, secondary varicocele, including nutcracker syndrome, and varicocele caused by compression from abdominal or retroperitoneal tumors; (2) Patients with severe oligozoospermia and severe asthenozoospermia; Criteria: Sperm concentration <1×10^6/mL, sperm progressive motility (PR) <1%; (3) Patients who have taken medications related to the treatment of this disease, specifically kidney-nourishing and sperm-generating drugs, within the past month; (4) Patients with severe underlying primary diseases of the heart, liver, kidneys, or other systems, or mental disorders; (5) Patients with known allergies to any components of the investigational drug; (6) Patients who have participated in other clinical trials within the past three months prior to randomization; (7) Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sperm concentration;sperm forward motility;testicular volume;Semen Biochemical Analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale;Sperm DNA Fragmentation Rate;Maximum diameter of the spermatic vein (under Color Doppler Flow Imaging) during Valsalva maneuver.; | — |
Countries
China
Contacts
Department of Urology, the Second Affiliated Hospital of Nanjing Medical University.