Male infertility
Conditions
Interventions
Test group:Yishen Tongluo Formula Granules + Levocarnitine
Control group:Yishen Tongluo Formula Granule Simulator + Levocarnitine
Sponsors
Henan Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
22 Years to 48 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for "severe asthenozoospermia-induced infertility" according to Western medicine; (2) Meet the diagnostic criteria for "Kidney Deficiency and Meridian Obstruction pattern" according to traditional Chinese medicine; (3) Male patients aged between 22 and 48 years (inclusive); (4) No clear etiology identified after routine systemic baseline examinations and specialized urogenital evaluations; (5) Married and having regular sexual intercourse; (6) Understand the study content, voluntarily participate in the study, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Subjects whose spouse is diagnosed with female infertility; (2) Subjects diagnosed with azoospermia, teratozoospermia, or immunological infertility; (3) Age less than 22 years or greater than 48 years; (4) Subjects with a family history of genetic disorders; (5) Congenital malformations or dysplasia of the reproductive organs, or obstruction of the spermatic ducts; (6) Subjects complicated with severe primary diseases involving the cardiovascular and cerebrovascular systems, liver and kidney dysfunction, respiratory system, digestive system, nervous system, rheumatic immune system, endocrine system, hematopoietic system, etc.; (7) Subjects with psychological disorders or mental illness; (8) Subjects with active systemic infections; (9) Subjects with long-term unhealthy habits such as staying up late, frequent hot spring bathing, sauna use, wearing tight pants, as well as long-term heavy smoking, alcohol abuse, or exposure to radiation, high temperatures, or toxic/hazardous chemical environments, and who are unable or unwilling to change or abandon these habits in the short term; (10) Subjects with allergic constitution, a history of severe drug allergies, or allergy to one or more Chinese herbal ingredients in the study medication; (11) Subjects who have used similar drugs or other methods to improve semen quality within 3 months prior to the study; (12) Subjects who have taken medications affecting sperm quality, such as antiepileptics, antineoplastics, or hormones, within 3 months prior to the study; (13) Subjects who have participated in other clinical trials within 3 months prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive motility rate;Sperm concentration;sperm reactive oxygen species;sperm DNA fragmentation index;sperm mitochondrial membrane potential;Total fertilization rate and normal fertilization rate within 26 hours after ICSI;High-quality embryo rate on day 3 after ICSI;ß-hCG test on day 14 after embryo transfer;Clinical pregnancy rate at 4–7 weeks after embryo transfer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver and kidney function;Traditional Chinese Medicine (TCM) syndrome; | — |
Countries
Chain
Contacts
Public ContactSunzixue
Henan Provincial Hospital of Traditional Chinese Medicine (The Second Affiliated Hospital of Henan University of Chinese Medicine)
Outcome results
None listed