title: Intracytoplasmic morphologically selected sperm injection versus conventional intracytoplasmic sperm injection: a randomized controlled trial.
abstract: BACKGROUND
  Intracytoplasmic morphologically selected sperm injection (IMSI) is still proposed and employed in the clinical practice to improve the reproductive outcome in infertile couples scheduled for conventional intracytoplasmic sperm injection (cICSI). The aim of the current randomized controlled trial (RCT) was to test the hypothesis that IMSI gives a better live birth delivery rate than cICSI.
  
  
  METHODS
  Infertile couples scheduled for their first cICSI cycle for male factor were allocated using a simple randomization procedure. All available biological and clinical data were recorded and analyzed in a triple-blind fashion.
  
  
  RESULTS
  Our final analysis involved the first 121 patients (48 and 73 subjects for IMSI and cICSI arm, respectively) because the trial was stopped prematurely on the advice of the data safety and monitoring Committee because of concerns about IMSI efficacy at the first interim analysis. No significant difference between arms was detected in rates of clinical pregnancy per embryo transferred [11/34 (32.3%) vs. 15/64 (23.4%); odds ratio (OR) 1.56, 95% (confidence interval) CI 0.62-3.93, P = 0.343] and of live birth delivery [9/48 (18.8%) vs. 11/73 (15.1%); OR 1.30, 95%CI 0.49-3.42, P = 0.594).
  
  
  CONCLUSIONS
  Current data did not support the routine use of IMSI in the clinical practice for improving cICSI results in unselected infertile couples with male factor.
authors: Obstetrics and Gynecology Unit, Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.|University of Modena and Reggio Emilia, Via del Pozzo, 71, 41124, Modena, Italy.
authors: Giovanni Battista
authors: GB
authors: La Sala
authors: Obstetrics and Gynecology Unit, Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
authors: Alessia
authors: A
authors: Nicoli
authors: Obstetrics and Gynecology Unit, Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
authors: Eleonora
authors: E
authors: Fornaciari
authors: Obstetrics and Gynecology Unit, Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
authors: Angela
authors: A
authors: Falbo
authors: Obstetrics and Gynecology Unit, Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
authors: Ilaria
authors: I
authors: Rondini
authors: Obstetrics and Gynecology Unit, Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
authors: Daria
authors: D
authors: Morini
authors: Obstetrics and Gynecology Unit, Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
authors: Barbara
authors: B
authors: Valli
authors: Obstetrics and Gynecology Unit, Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.
authors: Maria Teresa
authors: MT
authors: Villani
authors: Obstetrics and Gynecology Unit, Arcispedale S. Maria Nuova of Reggio Emilia, IRCCS, Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy. stefanopalomba@tin.it.
authors: Stefano
authors: S
authors: Palomba
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011247:Pregnancy; D018873:Pregnancy Rate / Q000639:trends*; D020554:Sperm Injections, Intracytoplasmic / Q000379:methods*; D013094:Spermatozoa / Q000166:cytology* / Q000502:physiology*