title: A retrospective comparison of clinical outcomes and satisfaction using reconstituted recombinant gonadotropins (rFSH) or cartridge rFSH with a pen device in donor oocyte cycles.
abstract: BACKGROUND
  Use of recombinant follicle stimulating hormone (rFSH) in a cartridge pen device offers obvious benefits for donor oocyte cycles including the administration of fewer and more patient-friendly injectable medications.
  
  
  METHODS
  In a University-based IVF program, a total of 98 oocyte donor cycles using rFSH either reconstituted or as a pen device given to 118 recipients (eight split cycles) were retrospectively reviewed. Following discontinuation of oral contraceptive, controlled ovarian hyperstimulation was begun using either reconstituted rFSH (n = 19) or rFSH with a cartridge pen device (n = 79) (150-300 IU qd). GnRH-antagonists (Ganirelix, Organon) and an additional 75 IU of rFSH/day were begun when lead follicles were 13-14 mm in greatest diameter. The primary endpoints analyzed included cycle stimulation characteristics for each donor group and donor medication tolerance assessment with respect to each rFSH formulation, while secondary outcome measures included clinical pregnancy and implantation rates.
  
  
  RESULTS
  Oocyte donors using the pen required significantly less rFSH (2734 IU vs. 3276 IU, p < 0.05) and scored significantly higher medication tolerance scores (3.9 +/- 0.4 vs. 3.1 +/- 0.6, p < 0.05). No other differences in cycle stimulation for oocyte donors and clinical outcomes for recipients were seen including pregnancy rates (pen, 77% vs. reconstituted, 55%, p - NS) and clinical pregnancy rates (61% vs. 45%, p - NS). However, significantly greater implantation rates (57% vs. 31%, p < 0.01) occurred in the pen group.
  
  
  CONCLUSIONS
  Compared to reconstituted formulations, the pen device results in lower gonadotropin requirements and provides a simplified dosing method with better tolerance.
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: M S
authors.initials: MS
authors.lastname: Christianson
authors.forename: M A
authors.initials: MA
authors.lastname: Barker
authors.forename: C
authors.initials: C
authors.lastname: Schouweiler
authors.forename: S R
authors.initials: SR
authors.lastname: Lindheim
mesh_terms: D000328:Adult; D005260:Female; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage*; D006801:Humans; D007279:Injections, Subcutaneous / Q000295:instrumentation; D008597:Menstrual Cycle / Q000187:drug effects; D008875:Middle Aged; D018587:Oocyte Donation; D010062:Ovulation Induction / Q000295:instrumentation / Q000379:methods*; D017060:Patient Satisfaction; D011247:Pregnancy; D011994:Recombinant Proteins / Q000008:administration & dosage; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D005640:Follicle Stimulating Hormone