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

Male Infertility Clinical Trial

Official title:

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05792813
• Other study ID #: Xiyuannanke
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: shengjing liu, Phd.
• Phone: +86 01062835134
• Email: liu-shengjing[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 45 Years

Eligibility

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 exclusion criteria included any of the following:

1. infertility is caused by the inability to complete sexual intercourse, including but not limited to erectile dysfunction or ejaculatory disorders

2. with infertility caused by organic lesions of the reproductive system

3. with reproductive system infection, such as chlamydia trachomatis or mycoplasma infection

4. with palpable varicocele

5. with abnormal and clinical significance of sex hormone (FSH, LH, T)

6. complicated with liver and kidney dysfunction, severe basic diseases such as diabetes, cardiovascular and cerebrovascular diseases, mental diseases, malignant tumors, or serious organic diseases

7. with a history of allergy to any medicine or ingredients used in this study

8. receive other relevant treatment for the disease 2 weeks before treatment

Related Conditions & MeSH terms

• Asthenozoospermia
• Infertility
• Infertility, Male
• Male Infertility

Intervention

Drug:
• LGYY
LGYY = Linggui Yangyuan paste
• LGYY mimetic
LGYY = Linggui Yangyuan paste
• WZYZ
WZYZ= Wuzi Yanzong oral solution
• WZYZ mimetic
WZYZ= Wuzi Yanzong oral solution

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences	Chengdu Fifth People's Hospital, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Shenzhen Traditional Chinese Medicine Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment	TPMSC change from baseline to post-treatment	Baseline, 12 weeks
Secondary	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
Secondary	semen volume change from baseline to post-treatment	1) semen volume	Baseline, 4, 8, 12 weeks
Secondary	sperm density change from baseline to post-treatment	2) sperm density	Baseline, 4, 8, 12 weeks
Secondary	PR rate change from baseline to post-treatment	3) Semen parameter PR rate	Baseline, 4, 8, 12 weeks
Secondary	PR+NP rate change from baseline to post-treatment	4) PR+NP rate	Baseline, 4, 8, 12 weeks
Secondary	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)
Secondary	spouse pregnancy rate	difference in the number of pregnancies	Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)
Secondary	time to pregnancy	The time required for pregnancy in this study	Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)