title: Recruitment challenges of a multicenter randomized controlled varicocelectomy trial.
abstract: OBJECTIVE
  To review reasons for suboptimal recruitment for a randomized controlled trial (RCT) of varicocelectomy versus intrauterine insemination (IUI) for treatment of male infertility and to suggest means for improving future study recruitment.
  
  
  METHODS
  Survey of Reproductive Medicine Network (RMN) participating sites.
  
  
  METHODS
  Reproductive Medicine Network.
  
  
  METHODS
  None.
  
  
  METHODS
  None.
  
  
  METHODS
  Ascertain reasons for inadequate recruitment and suggest improvements for future varicocelectomy trails.
  
  
  RESULTS
  This study screened seven and enrolled three couples, with the first couple randomized on June 30, 2010. The study was subsequently stopped on March 30, 2011. The following themes were cited most frequently by sites and therefore determined to be most likely to have played a role in suboptimal recruitment: [1] men must be screened at the beginning of a couple's infertility evaluation, [2] inclusion of infertile women who had failed previous fertility interventions appeared to be associated with the couple's intolerance of a placebo arm, and [3] an apparent bias against the use of unstimulated IUI cycles indicated a prejudicial preference for surgical intervention in the male partner.
  
  
  CONCLUSIONS
  Improved recruitment may be realized through screening infertile men as early as possible while minimizing study-related time commitments. Focused patient education may promote improved equipoise and acceptance of a placebo arm in male infertility studies. Creative approaches to implementing varicocelectomy trials must be considered in addition to having a network of motivated researchers who carry a high volume of possible study participants because very large numbers may need to be screened to complete the clinical trial enrollment.
authors: Department of Urology, SUNY Upstate University Hospital, Syracuse, New York 13210, USA. trusselj@upstate.edu
authors: J C
authors: JC
authors: Trussell
authors: Gregory M
authors: GM
authors: Christman
authors: Dana A
authors: DA
authors: Ohl
authors: Richard S
authors: RS
authors: Legro
authors: Stephen A
authors: SA
authors: Krawetz
authors: Peter J
authors: PJ
authors: Snyder
authors: Pasquale
authors: P
authors: Patrizio
authors: Alex J
authors: AJ
authors: Polotsky
authors: Michael P
authors: MP
authors: Diamond
authors: Peter R
authors: PR
authors: Casson
authors: Christos
authors: C
authors: Coutifaris
authors: Kurt
authors: K
authors: Barnhart
authors: Robert G
authors: RG
authors: Brzyski
authors: William D
authors: WD
authors: Schlaff
authors: Randall
authors: R
authors: Meacham
authors: David
authors: D
authors: Shin
authors: Tracey
authors: T
authors: Thomas
authors: Meizhuo
authors: M
authors: Zhang
authors: Nanette
authors: N
authors: Santoro
authors: Esther
authors: E
authors: Eisenberg
authors: Heping
authors: H
authors: Zhang
mesh_terms: D000465:Algorithms; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic / Q000379:methods*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design / Q000706:statistics & numerical data; D013521:Urologic Surgical Procedures, Male / Q000379:methods; D014646:Varicocele / Q000601:surgery*