Clinical trial NCT05792813: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Male Infertility
Asthenozoospermia
Oligoasthenozoospermia
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
name: Shandong University of Traditional Chinese Medicine
name: Chengdu Fifth People's Hospital
name: Affiliated Hospital of Nanjing University of Chinese Medicine
First posted: 2023-03-31
Enrollment: 162
Sex: MALE
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in Total progressive motile sperm count (TPMSC) from baseline to post-treatment
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: The total sperm count change from baseline to post-treatment
timeFrame: Baseline, 4, 8, 12 weeks
measure: semen volume change from baseline to post-treatment
timeFrame: Baseline, 4, 8, 12 weeks
measure: sperm density change from baseline to post-treatment
timeFrame: Baseline, 4, 8, 12 weeks
measure: PR rate change from baseline to post-treatment
timeFrame: Baseline, 4, 8, 12 weeks
measure: PR+NP rate change from baseline to post-treatment
timeFrame: Baseline, 4, 8, 12 weeks
measure: Chinese Medicine Symptoms Score (CMSS) change from baseline to post-treatment
timeFrame: Baseline, 4, 8, 12 weeks of treatment and 12 weeks of follow-up (24 week)
measure: spouse pregnancy rate
timeFrame: Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)
measure: time to pregnancy
timeFrame: Baseline, 12 weeks of treatment and 12 weeks of follow-up (24 week)
Other outcomes:
Locations:
Study officials:
References: