Asthenospermia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Married men aged 22 to 40 (including 22 and 40); (2) Meet the diagnostic criteria for male infertility; (3) meet the Western diagnostic criteria for asthenospermia; (4) Conforming to TCM syndrome differentiation standards of kidney and essence deficit syndrome; (5) normal development of reproductive organs; (6) Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: (1) Infertility caused by chromosomal abnormalities (such as heterotopic Rothschild, Y chromosome microdeletion, etc.); (2) spermatic obstruction, varicocele or cryptorchidism; (3) orchitis, epididymitis, mycoplasma, chlamydia infection and other diseases affecting semen quality; (4) various causes of vaginal ejaculation dysfunction, such as no ejaculation, retrograde ejaculation and other sexual dysfunction; (5) Severe hepatic and renal insufficiency (alanine aminotransferase (ALT)>3×ULN, aspartate aminotransferase (AST)>3×ULN, urea nitrogen (BUN)>2×ULN, creatinine (Cr)>1×ULN), cardiovascular and cerebrovascular diseases, hematopoietic diseases; (6) Patients with poorly controlled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >100mmHg) or diabetes (fasting blood glucose >7mmol/L); (7) serious mental illness accompanied by mental abnormality or loss of self-care ability; (8) Allergic to the experimental drug; (9) Patients with chronic addiction to smoking or drinking that may affect their fertility, or those who cannot ban smoking or alcohol during the experiment, the specific criteria are as follows: ? Smoking history: those who smoked more than 5 cigarettes per day in the past 6 months; ? Drinking history: the average daily alcohol consumption in the past 6 months exceeded the following standards: beer 570 ml, red wine 200 ml or white wine 60 ml, each containing about 20 g alcohol; (10) Those who have failed to take the test drug before, or had adverse reactions that could not be tolerated; (11) Use of drugs that improve or affect sperm concentration or motility 1 month before screening; (12) Participants who had participated in other clinical trials within 3 months before screening; (13) According to the judgment of the investigator, there are others who are not suitable to participate in this clinical trial. (6) Voluntary signing of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PR sperm rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PR sperm rate;PR+NP sperm rate;Total effective sperm count;Change value of TCM syndrome score;Spouse pregnancy rate;Sperm DNA fragmentation index; | — |
Countries
China
Contacts
Xiyuan Hospital of CACMS