Male infertility associated with varicocele
Conditions
Interventions
Control Group:Mai Zhiling + L-carnitine
Experimental Group:Guang Sizi Tong Qu Tang + L-carnitine
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
Male
Age
23 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western medicine diagnostic criteria for male infertility. (2) Meets the Western medicine diagnostic criteria for mild-to-moderate semen quality abnormality. (3) Meets the Western medicine diagnostic criteria for clinical grade I–II varicocele. (4) Meets the TCM syndrome differentiation criteria for kidney deficiency and blood stasis pattern. (5) Aged 23 to 45 years (inclusive). (6) Able to maintain regular sexual intercourse. (7) Has not received treatment with the same class of drugs or other therapies within 2 weeks prior to the study. (8) The subject provides informed consent and voluntarily signs the informed consent form. Patients who meet all of the above eight criteria will be included in the study; otherwise, they will not be included.
Exclusion criteria
Exclusion criteria: (1) Spouse (female partner) aged =35 years, or assessed as having female factor(s) that may cause infertility. (2) Unilateral or bilateral subclinical or recurrent varicocele. (3) Abnormal male hormone levels. (4) Severe systemic diseases: poorly controlled severe underlying systemic diseases, including cardiovascular diseases, respiratory diseases, hepatic or renal insufficiency (defined as liver function Child-Pugh class B or above, or renal function with eGFR 8%), etc. (5) Significant environmental and lifestyle exposures: history of long-term heavy smoking (e.g., =20 cigarettes per day), alcohol consumption (e.g., daily alcohol intake =40 g), or long-term occupational or environmental exposure to high temperatures, radiation, and toxic chemicals (such as lead, mercury, benzene, etc.). Meeting any one of the above criteria constitutes meeting the exclusion criteria and requires exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of sperm with progressive motility;Sperm concentration;Sperm DNA Fragmentation Rate;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactLi Haisong
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed