title: A prospective randomized noninferiority study comparing recombinant FSH and highly purified menotropin in intrauterine insemination cycles in couples with unexplained infertility and/or mild-moderate male factor.
abstract: OBJECTIVE
  To demonstrate the noninferiority of highly purified menotropin (HP-hMG) compared with recombinant FSH (rFSH) regarding clinical pregnancy rate (PR) in intrauterine insemination (IUI) cycles.
  
  
  METHODS
  Prospective randomized noninferiority trial.
  
  
  METHODS
  Unit of physiopathology of human reproduction, university hospital.
  
  
  METHODS
  Five hundred twenty-three patients with unexplained infertility or mild male infertility undergoing controlled ovarian hyperstimulation for IUI.
  
  
  METHODS
  Patients were randomized for treatment with rFSH (262 patients) or HP-hMG (261 patients). Insemination was performed 34-36 hours after hCG injection.
  
  
  METHODS
  The primary outcome was clinical pregnancy rate (PR). The secondary outcome was the number of interrupted cycles for high risk of ovarian hyperstimulation syndrome (OHSS) and multiple pregnancy.
  
  
  RESULTS
  The clinical PR was 19.7% (95% confidence interval [CI] 15.3%-25.1%) in the HP-hMG group and 21.4% (95% CI 16.9%-26.8%) in the rFSH group [absolute difference -1.7% (95% CI -8.6%-5.2%)]; therefore, the noninferiority was demonstrated. The number of interrupted cycles for OHSS risk and multiple pregnancy was significantLy higher in the rFSH group, 8.4% (95% CI 5.6%-12.4%) than in the HP-hMG group 1.2% (95% CI 0.4%-3.3%) [absolute difference -7.27% (95% CI -11.3 to -3.7)].
  
  
  CONCLUSIONS
  HP-hMG is not inferior compared with rFSH regarding clinical PR.
authors.affiliation: Department of Obstetrics and Gynaecology, Università Cattolica del Sacro Cuore, Rome, Italy. francescasagnella@libero.it
authors.forename: Francesca
authors.initials: F
authors.lastname: Sagnella
authors.forename: Francesca
authors.initials: F
authors.lastname: Moro
authors.forename: Antonio
authors.initials: A
authors.lastname: Lanzone
authors.forename: Anna
authors.initials: A
authors.lastname: Tropea
authors.forename: Daniela
authors.initials: D
authors.lastname: Martinez
authors.forename: Antonio
authors.initials: A
authors.lastname: Capalbo
authors.forename: Maria Francesca
authors.initials: MF
authors.lastname: Gangale
authors.forename: Valentina
authors.initials: V
authors.lastname: Spadoni
authors.forename: Andrea
authors.initials: A
authors.lastname: Morciano
authors.forename: Rosanna
authors.initials: R
authors.lastname: Apa
mesh_terms: D000328:Adult; D000465:Algorithms; D005191:Family Characteristics; D005260:Female; D005300:Fertility Agents, Female / Q000627:therapeutic use; D005640:Follicle Stimulating Hormone / Q000627:therapeutic use*; D006801:Humans; D007246:Infertility / Q000628:therapy*; D007248:Infertility, Male / Q000145:classification / Q000628:therapy*; D007315:Insemination, Artificial / Q000379:methods; D008297:Male; D008596:Menotropins / Q000302:isolation & purification / Q000627:therapeutic use*; D008597:Menstrual Cycle / Q000502:physiology; D011247:Pregnancy; D018873:Pregnancy Rate; D011994:Recombinant Proteins / Q000627:therapeutic use; D012720:Severity of Illness Index; D014599:Uterus
chemical_list: D005300:Fertility Agents, Female; D011994:Recombinant Proteins; D008596:Menotropins; D005640:Follicle Stimulating Hormone