Male infertility affects millions of males worldwide and is rising in prevalence due to social and environmental conditions. Asthenozoospermia (AZS) and oligoasthenozoospermia (OA) are the major causes of male infertility. The diagnosis of male infertility has a negative effect on men's physical and psychological status, poses a threat to their social relationships, lowers self-esteem, and disrupts family harmony. At present, the treatment of ASZ and OA are all mostly empirical, including antioxidants, endocrine therapy, and anti-infection. However, there are still limitations due to inefficiencies. Linggui Yangyuan paste (LGYY), a traditional Chinese compound herbal past, had been used to treat ASZ and OA for several years at the Xiyuan Hospital of China Academy of Chinese Medical Sciences. The investigators designed this program to study the efficacy and safety of LGYY for the treatment of patients with male infertility (AZS and OA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
162
LGYY = Linggui Yangyuan paste
LGYY = Linggui Yangyuan paste
WZYZ= Wuzi Yanzong oral solution
WZYZ= Wuzi Yanzong oral solution
Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment
TPMSC change from baseline to post-treatment
Time frame: Baseline, 12 weeks
The total sperm count change from baseline to post-treatment
the total sperm count change from baseline to post-treatment
Time frame: Baseline, 4, 8, 12 weeks
semen volume change from baseline to post-treatment
1\) semen volume
Time frame: Baseline, 4, 8, 12 weeks
sperm density change from baseline to post-treatment
2\) sperm density
Time frame: Baseline, 4, 8, 12 weeks
PR rate change from baseline to post-treatment
3\) Semen parameter PR rate
Time frame: Baseline, 4, 8, 12 weeks
PR+NP rate change from baseline to post-treatment
4\) PR+NP rate
Time frame: Baseline, 4, 8, 12 weeks
Chinese Medicine Symptoms Score (CMSS) change from baseline to post-treatment
Scores range from 0 to 33 with higher scores indicating greater burden of symptoms.
Time frame: Baseline, 4, 8, 12 weeks of treatment and 12 weeks of follow-up (24 week)
spouse pregnancy rate
difference in the number of pregnancies
Time frame: Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)
time to pregnancy
The time required for pregnancy in this study
Time frame: Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.