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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
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Trials

ISSN: 1745-6215