Status:
UNKNOWN
A Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia, Asthenia, and Teratozoospermia
Lead Sponsor:
Jinling Hospital, China
Conditions:
Oligospermia
Eligibility:
MALE
18-60 years
Phase:
PHASE4
Brief 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...
Detailed Description
The WHO defines infertility as a condition in which a couple cohabitates and has normal sex, has not used contraception for more than a year and the woman has not been able to conceive naturally.Some ...
Eligibility Criteria
Inclusion
- Diagnosed as oligoasthenospermia according to the World Health Organization Laboratory Manual for Human Semen Examination and Treatment (5th edition);
- 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
- 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.
- Testicular volume \< 12ml (B-ultrasonic measurement).
- BMI \< 18.5 or \> 32.
- Chromosomal karyotype abnormalities.
- Patients with endocrine diseases.
- Exposure to an occupation or environment with reproductive toxicity.
- Drug therapy to improve semen quality has been used in the past 2 weeks.
- Hepatobiliary disease, severe renal insufficiency, clinical disease or history of medication known to reduce fertility.
- A known or suspected history of allergy to experimental drugs and similar products.
- Any circumstance that the investigator considers to be likely to interfere with participation in the study or assessment.
Key Trial Info
Start Date :
December 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05320536
Start Date
December 6 2021
End Date
December 31 2022
Last Update
April 11 2022
Active Locations (4)
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1
Center for Reproductive Medicine, Jinling Hospital
Nanjing, Jiangsu, China, 210000
2
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
3
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Jiangsu, China
4
Xi 'an Tangdu Hospital
Xi’an, Jiangsu, China