Evaluation of a pen device for self-administration of recombinant human FSH in clomiphene citrate-resistant anovulatory women undergoing ovulation induction.
This open-label multicentre study evaluated ease of use, safety, and efficacy of a pen device for self-administration of recombinant follicle-stimulating hormone (rFSH) in 43 subjects undergoing ovulation induction. Follitropin beta was administered subcutaneously with the Follistim Pen within 3 days of onset of menses. A 75 IU starting dose could be increased by 25 or 50 IU on days 8 and 15 if no ovarian response was observed. Human chorionic gonadotrophin (HCG; 10,000 IU) was administered when one follicle > or =18 mm or two to three follicles > or =15 mm were observed. Subjects received standardized instruction for the pen device and subject comprehension was recorded as subjects practised and prepared injections. Ease of use was also evaluated by questionnaire. Forty-four subjects enrolled; 43 were treated with rFSH and 41 were treated with HCG. The comprehension questionnaire revealed that during the mock injection, 100% of subjects properly loaded the cartridge into the pen device, while 95% selected the correct dose and 100% self-injected the medication prescribed. During the second actual injection, 100% of subjects comprehended these pen-related steps. The ease-of-use questionnaire showed that 100% of the subjects rated the overall experience of self-administering with the pen as 'very good' to 'good'. Mean duration and total amount of follitropin beta were 11.4 +/- 4.2 days and 1070.3 +/- 580.3 IU respectively. Ovulation rate was 95%. Biochemical and ongoing pregnancy rates per attempt were 34.9 and 30.2% respectively. Three subjects experienced serious adverse events [asthma; ovarian hyperstimulation syndrome (OHSS) and pain; OHSS]. In conclusion, the pen device provides an easy, safe, and effective way for women to self-administer follitropin beta during ovarian stimulation.