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

Primary Purpose

Male Infertility, Asthenozoospermia, Oligoasthenozoospermia

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
LGYY
LGYY mimetic
WZYZ
WZYZ mimetic
Sponsored by
Xiyuan Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Infertility

Eligibility Criteria

22 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    LGYY+ WZYZ mimetic

    WZYZ + LGYY mimetic

    Outcomes

    Primary Outcome Measures

    Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment
    TPMSC change from baseline to post-treatment

    Secondary Outcome Measures

    The total sperm count change from baseline to post-treatment
    the total sperm count change from baseline to post-treatment
    semen volume change from baseline to post-treatment
    1) semen volume
    sperm density change from baseline to post-treatment
    2) sperm density
    PR rate change from baseline to post-treatment
    3) Semen parameter PR rate
    PR+NP rate change from baseline to post-treatment
    4) PR+NP rate
    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.
    spouse pregnancy rate
    difference in the number of pregnancies
    time to pregnancy
    The time required for pregnancy in this study

    Full Information

    First Posted
    March 8, 2023
    Last Updated
    April 24, 2023
    Sponsor
    Xiyuan Hospital of China Academy of Chinese Medical Sciences
    Collaborators
    First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Chengdu Fifth People's Hospital, Shenzhen Traditional Chinese Medicine Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05792813
    Brief Title
    Efficacy and Safety of Linggui Yangyuan Paste in Patients With Male Infertility
    Official Title
    Xiyuan Hospital of China Academy of Chinese Medical Sciences
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xiyuan Hospital of China Academy of Chinese Medical Sciences
    Collaborators
    First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Chengdu Fifth People's Hospital, Shenzhen Traditional Chinese Medicine Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Male Infertility, Asthenozoospermia, Oligoasthenozoospermia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    162 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    LGYY+ WZYZ mimetic
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    WZYZ + LGYY mimetic
    Intervention Type
    Drug
    Intervention Name(s)
    LGYY
    Intervention Description
    LGYY = Linggui Yangyuan paste
    Intervention Type
    Drug
    Intervention Name(s)
    LGYY mimetic
    Intervention Description
    LGYY = Linggui Yangyuan paste
    Intervention Type
    Drug
    Intervention Name(s)
    WZYZ
    Intervention Description
    WZYZ= Wuzi Yanzong oral solution
    Intervention Type
    Drug
    Intervention Name(s)
    WZYZ mimetic
    Intervention Description
    WZYZ= Wuzi Yanzong oral solution
    Primary Outcome Measure Information:
    Title
    Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment
    Description
    TPMSC change from baseline to post-treatment
    Time Frame
    Baseline, 12 weeks
    Secondary Outcome Measure Information:
    Title
    The total sperm count change from baseline to post-treatment
    Description
    the total sperm count change from baseline to post-treatment
    Time Frame
    Baseline, 4, 8, 12 weeks
    Title
    semen volume change from baseline to post-treatment
    Description
    1) semen volume
    Time Frame
    Baseline, 4, 8, 12 weeks
    Title
    sperm density change from baseline to post-treatment
    Description
    2) sperm density
    Time Frame
    Baseline, 4, 8, 12 weeks
    Title
    PR rate change from baseline to post-treatment
    Description
    3) Semen parameter PR rate
    Time Frame
    Baseline, 4, 8, 12 weeks
    Title
    PR+NP rate change from baseline to post-treatment
    Description
    4) PR+NP rate
    Time Frame
    Baseline, 4, 8, 12 weeks
    Title
    Chinese Medicine Symptoms Score (CMSS) change from baseline to post-treatment
    Description
    Scores range from 0 to 33 with higher scores indicating greater burden of symptoms.
    Time Frame
    Baseline, 4, 8, 12 weeks of treatment and 12 weeks of follow-up (24 week)
    Title
    spouse pregnancy rate
    Description
    difference in the number of pregnancies
    Time Frame
    Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)
    Title
    time to pregnancy
    Description
    The time required for pregnancy in this study
    Time Frame
    Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    shengjing liu, Phd.
    Phone
    +86 01062835134
    Email
    liu-shengjing@qq.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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