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

Early Phase 1

Not yet recruiting

• Conditions: Male Infertility; Asthenozoospermia; Oligoasthenozoospermia
• Interventions: Drug: LGYY mimetic; Drug: LGYY; Drug: WZYZ; Drug: WZYZ mimetic

• Registration Number: NCT05792813
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-03-31
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-27
• Study Start: 2023-06
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	LGYY mimetic	WZYZ + LGYY mimetic
Control group	WZYZ	WZYZ + LGYY mimetic
Experimental group	LGYY	LGYY+ WZYZ mimetic
Experimental group	WZYZ mimetic	LGYY+ WZYZ mimetic

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
PR rate change from baseline to post-treatment	Baseline, 4, 8, 12 weeks	3) Semen parameter PR rate
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
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
sperm density change from baseline to post-treatment	Baseline, 4, 8, 12 weeks	2) sperm density
PR+NP rate change from baseline to post-treatment	Baseline, 4, 8, 12 weeks	4) PR+NP rate
semen volume change from baseline to post-treatment	Baseline, 4, 8, 12 weeks	1) semen volume
time to pregnancy	Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)	The time required for pregnancy in this study