title: Administration of recombinant human FSH (solution in cartridge) with a pen device in women undergoing ovarian stimulation.
abstract: This study evaluated the first multiple-use pen device for the self-administration of recombinant FSH. The pen device is used for the subcutaneous injection of a pre-mixed ready-to-use solution of follitropin beta from a multiple-dose cartridge, and has flexible dosing capabilities. In the ease-of-use questionnaire, 90% of subjects rated the overall experience of self-injecting follitropin beta using the pen device as 'very good' (on day 6). The comprehension questionnaire revealed that prior to the first injection and during the second injection, the follitropin beta cartridge was properly loaded into the pen device by 96.7 and 100% of the subjects respectively. The questionnaire also showed that the correct dose was selected and self-administered by 98.3 and 100% of the subjects respectively. Biochemical and ongoing pregnancy rates per attempt were 56.7 and 45.0% respectively. The pen device is safe, effective, and easy to use for self-administering recombinant FSH during ovarian stimulation.
authors.affiliation: Reproductive Science Center of Boston, Waltham, MA, USA.
authors.forename: S
authors.initials: S
authors.lastname: Pang
authors.forename: B
authors.initials: B
authors.lastname: Kaplan
authors.forename: V
authors.initials: V
authors.lastname: Karande
authors.forename: L M
authors.initials: LM
authors.lastname: Westphal
authors.forename: R
authors.initials: R
authors.lastname: Scott
authors.forename: C
authors.initials: C
authors.lastname: Givens
authors.forename: P
authors.initials: P
authors.lastname: Sacks
mesh_terms: D000293:Adolescent; D000328:Adult; D004359:Drug Therapy, Combination; D004624:Embryo Transfer; D005069:Evaluation Studies as Topic; D005260:Female; D005307:Fertilization in Vitro; D037201:Follicle Stimulating Hormone, beta Subunit / Q000008:administration & dosage* / Q000009:adverse effects; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006727:Hormone Antagonists / Q000008:administration & dosage; D006801:Humans; D007279:Injections, Subcutaneous / Q000295:instrumentation* / Q000379:methods; D010062:Ovulation Induction; D011247:Pregnancy; D011256:Pregnancy Outcome; D012646:Self Administration / Q000295:instrumentation / Q000379:methods; D011795:Surveys and Questionnaires
chemical_list: D037201:Follicle Stimulating Hormone, beta Subunit; D006727:Hormone Antagonists; D007987:Gonadotropin-Releasing Hormone; C061018:ganirelix