Skip to main content

Table 1 Schedule of the study process

From: A double-blinded, randomized placebo-controlled trial on the effect of traditional Chinese medicine formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters

Time duration
Time point
Study period
Recruitment by reproductive practitioner Allocation by TCM team Post allocation
1st visit 0 week 1–6 weeks 2nd visita 7–12 weeks 3rd visita 3–6 months 4th visita 6–12 months
Enrollment:
 Eligibility screen X         
 Informed consent X         
 Allocation   X        
Interventions
 Administration of investigational product    X   X     
Assessments
 Semen analyses   X   X   X   X  
 Blood tests   X     X    
 Sperm DNA fragmentation   X   X   X   X  
 Sperm cryotolerance   X   X   X   X  
 Endocrine-disrupting chemicals test   X   X   X   X  
 DNA maturity assay   X   X   X   X  
 Liver and renal function assessment   X     X    
 Natural conception and pregnancy outcomeb          X
  1. a The 2nd through 4th visits are scheduled at the end of the time duration
  2. b Natural conception and pregnancy outcome are recorded by phone follow-up