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

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Asthenozoospermia; Male Infertility; Oligoasthenozoospermia

Treatments: Drug: WZYZ mimetic; Drug: LGYY mimetic; Drug: LGYY; Drug: WZYZ

Study type: Interventional

Funder types: Other

Identifiers

NCT05792813

Xiyuannanke

Details and patient eligibility

About

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).

Enrollment: 162 estimated patients

Sex: Male

Ages: 22 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 2 patient groups

Experimental group

Experimental group

Description:

LGYY+ WZYZ mimetic

Treatment:

Drug: LGYY

Drug: WZYZ mimetic

Control group

Active Comparator group

Description:

WZYZ + LGYY mimetic

Treatment:

Drug: LGYY mimetic

Drug: WZYZ