Male infertility associated with varicocele
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1: Meets the Western medical diagnostic criteria for male infertility. 2: Meets the Western medical diagnostic criteria for abnormal semen quality. 3: Meets the Western medical diagnostic criteria for clinical grade II–III varicocele. 4: Meets the TCM diagnostic criteria for kidney deficiency and blood stasis syndrome. 5: Aged between 23 and 45 years (inclusive). 6: Able to maintain regular sexual activity. 7: No use of similar medications or other therapies within the past 2 weeks prior to the study. 8: The participant is fully informed and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1: Spouse's age =35 years, or assessed to have female factors that may lead to infertility; 2: Unilateral or bilateral subclinical or recurrent varicocele; 3: Azoospermia; 4: Abnormal hormone levels; 5: Severe systemic diseases: Poorly controlled severe systemic underlying diseases, including cardiovascular diseases, respiratory system diseases, hepatic and renal insufficiency (defined as Child-Pugh grade B or above for liver function, or eGFR 8%), etc.; 6: Significant environmental and lifestyle exposures: History of long-term heavy smoking (e.g., =20 cigarettes per day), alcohol consumption (e.g., =40g of alcohol per day), or long-term exposure to high temperatures, radiation, and toxic chemicals (e.g., lead, mercury, benzene, etc.) in occupation or environment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy rate;live birth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of sperm with progressive motility;Sperm concentration;Sperm DNA Fragmentation Rate;TCM Syndrome Evaluation Scale; | — |
Countries
China
Contacts
Beijing University of Chinese Medicine Dongzhimen Hospital