Asthenozoospermia, Male Infertility, Oligoasthenozoospermia
Conditions
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).
Interventions
DRUGLGYY
LGYY = Linggui Yangyuan paste
DRUGLGYY mimetic
LGYY = Linggui Yangyuan paste
DRUGWZYZ
WZYZ= Wuzi Yanzong oral solution
DRUGWZYZ mimetic
WZYZ= Wuzi Yanzong oral solution
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Shandong University of Traditional Chinese Medicine
Chengdu Fifth People's Hospital
Affiliated Hospital of Nanjing University of Chinese Medicine
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
22 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* The participants must meet all following criteria at the time of randomization to be eligible for recruitment : 1. 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 2. Study participants met the diagnostic criteria for AZS or OA For AZS: 1. sperm concentration ≥15 × 106/ mL 2. PR \<32% For OA: 1. sperm concentration \<15 × 106/ mL 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment | Baseline, 12 weeks | TPMSC change from baseline to post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| semen volume change from baseline to post-treatment | Baseline, 4, 8, 12 weeks | 1\) semen volume |
| sperm density change from baseline to post-treatment | Baseline, 4, 8, 12 weeks | 2\) sperm density |
| PR rate change from baseline to post-treatment | Baseline, 4, 8, 12 weeks | 3\) Semen parameter PR rate |
| The total sperm count change from baseline to post-treatment | Baseline, 4, 8, 12 weeks | the total sperm count change from baseline to post-treatment |
| Chinese Medicine Symptoms Score (CMSS) change from baseline to post-treatment | Baseline, 4, 8, 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 |
| PR+NP rate change from baseline to post-treatment | Baseline, 4, 8, 12 weeks | 4\) PR+NP rate |
Contacts
Primary Contactshengjing liu, Phd.
Outcome results
None listed