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

Xiyuan Hospital of China Academy of Chinese Medical Sciences

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Male Infertility; Asthenozoospermia; Oligoasthenozoospermia
• Intervention / Treatment: Drug: LGYY; Drug: WZYZ mimetic; Drug: LGYY mimetic; Drug: WZYZ

• Study Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: shengjing liu, Phd.; Phone Number: +86 01062835134; Email: liu-shengjing@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; LGYY+ WZYZ mimetic	Drug: LGYY; LGYY = Linggui Yangyuan paste; Drug: WZYZ mimetic; WZYZ= Wuzi Yanzong oral solution
Active Comparator: Control group; WZYZ + LGYY mimetic	Drug: LGYY mimetic; LGYY = Linggui Yangyuan paste; Drug: WZYZ; WZYZ= Wuzi Yanzong oral solution

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
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)
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)

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine; Chengdu Fifth People's Hospital; Shandong University of Traditional Chinese Medicine; Shenzhen Traditional Chinese Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Male; Asthenozoospermia
• Other Study ID Numbers: Xiyuannanke

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No