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| Name | Class |
|---|---|
| First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | OTHER |
| Shandong University of Traditional Chinese Medicine | OTHER |
| Chengdu Fifth People's Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | LGYY+ WZYZ mimetic |
|
| Control group | Active Comparator | WZYZ + LGYY mimetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGYY | Drug | LGYY = Linggui Yangyuan paste |
| |
| LGYY mimetic |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment | TPMSC change from baseline to post-treatment | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The total sperm count change from baseline to post-treatment | the total sperm count change from baseline to post-treatment | Baseline, 4, 8, 12 weeks |
| semen volume change from baseline to post-treatment |
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Inclusion Criteria:
The participants must meet all following criteria at the time of randomization to be eligible for recruitment :
For AZS:
For OA:
Exclusion Criteria:
The trial exclusion criteria included any of the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shengjing liu, Phd. | Contact | +86 01062835134 | liu-shengjing@qq.com |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D053627 | Asthenozoospermia |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| Affiliated Hospital of Nanjing University of Chinese Medicine | OTHER |
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| Drug |
LGYY = Linggui Yangyuan paste |
|
| WZYZ | Drug | WZYZ= Wuzi Yanzong oral solution |
|
| WZYZ mimetic | Drug | WZYZ= Wuzi Yanzong oral solution |
|
1) semen volume
| Baseline, 4, 8, 12 weeks |
| sperm density change from baseline to post-treatment | 2) sperm density | Baseline, 4, 8, 12 weeks |
| PR rate change from baseline to post-treatment | 3) Semen parameter PR rate | Baseline, 4, 8, 12 weeks |
| PR+NP rate change from baseline to post-treatment | 4) PR+NP rate | 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. | Baseline, 4, 8, 12 weeks of treatment and 12 weeks of follow-up (24 week) |
| spouse pregnancy rate | difference in the number of pregnancies | Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week) |
| time to pregnancy | The time required for pregnancy in this study | Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week) |
| D052801 |
| Male Urogenital Diseases |