Efficacy and Safety of Linggui Yangyuan Paste in Patients With Male Infertility
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group LGYY+ WZYZ mimetic |
Drug: LGYY
LGYY = Linggui Yangyuan paste
Drug: WZYZ mimetic
WZYZ= Wuzi Yanzong oral solution
|
| Active Comparator: Control group WZYZ + LGYY mimetic |
Drug: LGYY mimetic
LGYY = Linggui Yangyuan paste
Drug: WZYZ
WZYZ= Wuzi Yanzong oral solution
|
Outcome Measures
Primary Outcome Measures
- Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment [Baseline, 12 weeks]
TPMSC change from baseline to post-treatment
Secondary Outcome Measures
- The total sperm count change from baseline to post-treatment [Baseline, 12 weeks]
the total sperm count change from baseline to post-treatment
- semen volume change from baseline to post-treatment [Baseline, 12 weeks]
1) semen volume
- sperm density change from baseline to post-treatment [Baseline, 12 weeks]
2) sperm density
- PR rate change from baseline to post-treatment [Baseline, 12 weeks]
3) Semen parameter PR rate
- PR+NP rate change from baseline to post-treatment [Baseline, 12 weeks]
4) PR+NP rate
- Chinese Medicine Symptoms Score (CMSS) change from baseline to post-treatment [Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)]
Scores range from 0 to 33 with higher scores indicating greater burden of symptoms.
- spouse pregnancy rate [Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)]
difference in the number of pregnancies
- time to pregnancy [Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)]
The time required for pregnancy in this study
Eligibility Criteria
Criteria
Inclusion Criteria:
- The participants must meet all following criteria at the time of randomization to be eligible for recruitment :
-
Study participants met the diagnostic criteria for male infertility 1)inability to have a child after at least 1 year of marriage with regular sexual life and without using any preventive methods 2)normal fertile female partner
-
Study participants met the diagnostic criteria for AZS or OA
For AZS:
-
sperm concentration ≥15 × 106/ mL
-
PR <32%
For OA:
-
sperm concentration <15 × 106/ mL
-
PR <32% (3) Study participants met the TCM diagnosis criteria for kidney deficiency and blood stasis (4) Men aged 22 to 45 years (5) The participants signed informed consent forms
Exclusion Criteria:
- The trial exclusion criteria included any of the following:
-
infertility is caused by the inability to complete sexual intercourse, including but not limited to erectile dysfunction or ejaculatory disorders
-
with infertility caused by organic lesions of the reproductive system
-
with reproductive system infection, such as chlamydia trachomatis or mycoplasma infection
-
with palpable varicocele
-
with abnormal and clinical significance of sex hormone (FSH, LH, T)
-
complicated with liver and kidney dysfunction, severe basic diseases such as diabetes, cardiovascular and cerebrovascular diseases, mental diseases, malignant tumors, or serious organic diseases
-
with a history of allergy to any medicine or ingredients used in this study
-
receive other relevant treatment for the disease 2 weeks before treatment
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Shandong University of Traditional Chinese Medicine
- Chengdu Fifth People's Hospital
- Shenzhen Traditional Chinese Medicine Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Xiyuannanke