title: An observational study of assisted reproductive technology outcomes in new European Union member states: an overview of protocols used for ovarian stimulation.
abstract: BACKGROUND
  The development of new fertility treatment options has facilitated individualized assisted reproductive technology (ART) protocols to improve outcomes. Manufacturing improvements to recombinant human follitropin alfa have allowed precise dosing based on mass (filled-by-mass; FbM) rather than bioactivity (filled-by-bioassay; FbIU). Continued monitoring and reporting of follitropin alfa treatment outcomes in routine clinical practice is essential.
  
  
  OBJECTIVE
  To provide an overview of the frequency of different controlled ovarian-stimulation protocols used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles in new European Union member states, and to provide post-registration efficacy and safety data on follitropin alfa.
  
  
  METHODS
  A 2-year, prospective, observational, multicentre, Phase IV study conducted at ART clinics in the Czech Republic, Estonia, Latvia, Lithuania, Poland, Slovakia and Slovenia. Women aged 18-47 years undergoing ovarian stimulation with follitropin alfa for conventional IVF or ICSI were eligible for inclusion. The main treatment outcome was cumulative clinical pregnancy rate. Data were analysed descriptively.
  
  
  RESULTS
  Clinical pregnancy outcomes were available for 4055 of 4085 (99.3%) patients. In total, 1897 (46.8%) patients used follitropin alfa FbIU; 2133 (52.6%) used follitropin alfa FbM. Clinical pregnancy was achieved by 39.5% (1603/4055) of patients. A greater proportion of patients with polycystic ovary syndrome achieved a clinical pregnancy than those with endometriosis (41.8% vs 37.8%, respectively). A higher cumulative pregnancy rate was observed with the use of follitropin alfa FbM than follitropin alfa FbIU (41.3% vs 37.8%, respectively; p = 0.02).
  
  
  CONCLUSIONS
  This study represents the most comprehensive audit of individualized ART in clinical practice in Central and Eastern Europe. Overall, clinical pregnancy was achieved by 39.5% of patients after stimulation with follitropin alfa. The use of follitropin alfa FbM resulted in a higher cumulative pregnancy rate than did the FbIU formulation. However, limitations of the study include the observational and non-comparative study design, and descriptive nature of statistical analyses; furthermore, the study was not designed to make direct comparisons between the success rates of different ovarian-stimulation protocols.
authors.affiliation: Department of Reproductive Medicine, University Clinical Centre Maribor, Ljubljanska 5, Maribor, Slovenia. vlai@ukc-mb.si
authors.forename: Veljko
authors.initials: V
authors.lastname: Vlaisavljević
authors.forename: Helena
authors.initials: H
authors.lastname: Meden-Vrtovec
authors.forename: Piotr
authors.initials: P
authors.lastname: Lewandowski
authors.forename: Michał
authors.initials: M
authors.lastname: Radwan
authors.forename: Alena
authors.initials: A
authors.lastname: Langerova
authors.forename: Milan
authors.initials: M
authors.lastname: Vicena
authors.forename: Jozef
authors.initials: J
authors.lastname: Války
authors.forename: Miroslav
authors.initials: M
authors.lastname: Herman
authors.forename: Audronë
authors.initials: A
authors.lastname: Usoniene
authors.forename: Gints
authors.initials: G
authors.lastname: Treijs
mesh_terms: D000293:Adolescent; D000328:Adult; D002626:Chemistry, Pharmaceutical; D002985:Clinical Protocols; D005061:Europe, Eastern; D005260:Female; D005307:Fertilization in Vitro; D015292:Glycoprotein Hormones, alpha Subunit / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D010062:Ovulation Induction / Q000379:methods*; D011247:Pregnancy; D018873:Pregnancy Rate; D011446:Prospective Studies; D011994:Recombinant Proteins; D012449:Safety; D020554:Sperm Injections, Intracytoplasmic; D016896:Treatment Outcome
chemical_list: D015292:Glycoprotein Hormones, alpha Subunit; D011994:Recombinant Proteins