inggui Yangyuan Paste for patients with male infertility: a multicenter, double-blind, double-dummy, randomized controlled trial

Not Applicable

• Conditions: male infertility (asthenozoospermia and oligoasthenozoospermia)

• Registration Number: ITMCTR2023000009
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

(1) Study participants met the diagnostic criteria for male infertility
(2) Study participants met the diagnostic criteria for asthenozoospermia or oligoasthenozoospermia
(3) Study participants met the traditional Chinese medicine diagnosis criteria for kidney deficiency and blood stasis
(4) Men aged 22 to 45 years
(5) The participants signed informed consent forms

Exclusion Criteria

(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 (follicle stimulating, hormoneluteinizing, testosterone)
(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 & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total progressive motile sperm count;

Secondary Outcome Measures

Name	Time	Method
traditional chinese medicine symptom score;semen parameters (semen volume\sperm concentration\total sperm count\progressive motility\progressive motility+nonprogressive motility);time to pregnancy;pregnancy rate;