Efficacy and Safety of Linggui Yangyuan Paste in Patients With Male Infertility

Study Overview
=================
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).

Official Title
-----------------
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Conditions
-----------------
Male Infertility, Asthenozoospermia, Oligoasthenozoospermia

Intervention / Treatment
-----------------
* Drug: LGYY
* Drug: LGYY mimetic
* Drug: WZYZ
* Drug: WZYZ mimetic


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>LGYY+ WZYZ mimetic | Drug: LGYY<br>* LGYY = Linggui Yangyuan paste<br>Drug: WZYZ mimetic<br>* WZYZ= Wuzi Yanzong oral solution<br>|
| Active Comparator: Control group<br>WZYZ + LGYY mimetic | Drug: LGYY mimetic<br>* LGYY = Linggui Yangyuan paste<br>Drug: WZYZ<br>* WZYZ= Wuzi Yanzong oral solution<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |