A Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia, Asthenia, and Teratozoospermia

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The object of study for patients with idiopathic disease of OAT, the use of multicenter, randomized, double-blind, controlled, prospective clinical research, choose according to row, standard units of idiopathic male infertility clinics less weak abnormal sperm, randomly divided into experimental group and the placebo group, the comparison between the two groups of patients and semen parameters before and after medication, seminal plasma hormone, serum lipid levels and other indicators;At the same time, serum and seminal plasma samples of the two groups of patients before and after treatment were collected for bioinformatics analysis of protein spectrum to find the effector molecules of Gulingji capsule.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jinling Hospital, China

Criteria

Inclusion Criteria:

1. Diagnosed as oligoasthenospermia according to the World Health Organization Laboratory Manual for Human Semen Examination and Treatment (5th edition);

2. initial examination and reexamination of abnormal semen quality shall meet one of the following conditions: sperm density < 15×10^6 / mL or total sperm count < 39×10^6, proportion of forward motile sperm < 32% or total sperm viability < 40%, percentage of normal sperm < 4%.

Exclusion Criteria:

1. Leucospermia, with testis, epididymitis, prostatitis, severe genital trauma, testicular torsion, urinary tract infection, cryptorchidism, varicocele, and a history of serious medical conditions such as diabetes, tumor history, inguinal and genital surgery.

2. Testicular volume < 12ml (B-ultrasonic measurement).

3. BMI < 18.5 or > 32.

4. Chromosomal karyotype abnormalities.

5. Patients with endocrine diseases.

6. Exposure to an occupation or environment with reproductive toxicity.

7. Drug therapy to improve semen quality has been used in the past 2 weeks.

8. Hepatobiliary disease, severe renal insufficiency, clinical disease or history of medication known to reduce fertility.

9. A known or suspected history of allergy to experimental drugs and similar products.

10. Any circumstance that the investigator considers to be likely to interfere with participation in the study or assessment.