NCT05792813

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 8, 2023

Last Update Submit

April 24, 2023

Conditions

Male InfertilityAsthenozoospermiaOligoasthenozoospermia

Outcome Measures

Primary Outcomes (1)

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

    TPMSC change from baseline to post-treatment

    Baseline, 12 weeks

Secondary Outcomes (8)

  • The total sperm count change from baseline to post-treatment

    Baseline, 4, 8, 12 weeks

  • semen volume change from baseline to post-treatment

    Baseline, 4, 8, 12 weeks

  • sperm density change from baseline to post-treatment

    Baseline, 4, 8, 12 weeks

  • PR rate change from baseline to post-treatment

    Baseline, 4, 8, 12 weeks

  • PR+NP rate change from baseline to post-treatment

    Baseline, 4, 8, 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

LGYY+ WZYZ mimetic

Drug: LGYYDrug: WZYZ mimetic

Control group

ACTIVE COMPARATOR

WZYZ + LGYY mimetic

Drug: LGYY mimeticDrug: WZYZ

Interventions

LGYYDRUG

LGYY = Linggui Yangyuan paste

Experimental group
LGYY mimeticDRUG

LGYY = Linggui Yangyuan paste

Control group
WZYZDRUG

WZYZ= Wuzi Yanzong oral solution

Control group
WZYZ mimeticDRUG

WZYZ= Wuzi Yanzong oral solution

Experimental group

Eligibility Criteria

Age22 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, MaleAsthenozoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Central Study Contacts

shengjing liu, Phd.

CONTACT

+86 01062835134liu-shengjing@qq.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 31, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

April 27, 2023

Record last verified: 2023-03