Single-arm, observational study of the ease of use of a redesigned pen device to deliver recombinant human follicle-stimulating hormone (follitropin alfa) for assisted reproductive technology treatment

Figures & data

Table 1 Summary of the ease of use questionnaires and questions used to evaluate the primary and secondary endpoints

Endpoint	Questionnaire	Questions	Study visits used to assess endpoint
Primary
The proportion of patients rating the pen as easy to use at end of stimulation-phase visit	B	1, 2, 4–7, 9, 10, 13–19	End of stimulation visita
Secondary
The proportion of patients rating the pen as easy to:
Use	B	1, 2, 4–7, 9, 10, 13–19	3, 4, 5b
Learn	A	1–7	Stimulation day 1
Prepare for injection	B	7, 14, 15	3, 4, 5b
Deliver injection	B	1, 2, 4, 5, 9–11, 16, 17	3, 4, 5b
Dispose of after injection	B	18, 19	3, 4, 5b
The proportion of nurses rating the pen as easy to:
Use	C	3–16	End of recruitment
Learn	C	3	End of recruitment
Teach	C	5	End of recruitment

Notes:

a Visit 5 (end of follitropin alfa stimulation/r-hCG administration); however, if data were unavailable for this time point, then stimulation days 7–8 data were used.

b Visit 3 was on follitropin alfa stimulation days 5–6; visit 4 was on stimulation days 7–8; and visit 5 was the end of stimulation/r-hCG administration visit.

Abbreviation: r-hCG, recombinant human chorionic gonadotropin.

Figure 1 Patient disposition.

Notes: ^aOne patient had an incorrect trigger injection time; this meant that no oocyte pick-up was performed.
Abbreviations: OHSS, ovarian hyperstimulation syndrome; r-hCG, recombinant human chorionic gonadotropin; ITT, intent-to-treat.

Table 2 Patient demographics and other characteristics (intent-to-treat population)

		Intent-to-treat population (N=86)
Age (years)	Mean (SD)	35.8 (3.6)
	Range	26–42
Race (%)	Caucasian	82.6
	Asian	14.0
	Other	3.5
BMI (kg/m^2)a	Mean (SD)	23.2 (3.9)
	Range	17–35
Baseline FSH (IU/L)b	Mean (SD)	7.4 (2.5)
	Range	0.9–12.4
Baseline AMH (pmol/L)c	Mean (SD)	11.8 (10.0)
	Range	0.4–50.0
Number of previous	0	54.7
ART cycles (% of patients)	1	22.1
	2	17.4
	3	1.2
	4	1.2
	5–7	3.5

Notes:

a Data are reported for 84 patients.

b Data are reported for 68 patients.

c Data are reported for 82 patients.

Abbreviations: AMH, anti-Müllerian hormone; ART, assisted reproductive technology; BMI, body mass index; FSH, follicle-stimulating hormone; SD, standard deviation.

Figure 2 Proportion of patients who found the follitropin alfa pen easy to use (primary endpoint) (n=73).

Note: Error bars represent 95% confidence intervals.

Figure 3 Questionnaire B results – key questions to determine follitropin alfa pen ease of use (primary endpoint).

Notes: (A) Question 1, “The GONAL-f Pen allows me to know for sure when the injection has been completed” (n=76). (B) Question 10, “I am confident that I am injecting a complete dose of medication with the GONAL-f Pen” (n=76). (C) Question 15, “Overall, how do you rate your experience with setting (dialing in) the right dosage” (n=76).
Abbreviation: n, number.

Figure 4 Proportion of patients rating the follitropin alfa pen (easy to use/prepare/deliver/dispose) by visit (intent-to-treat population).

Note: Error bars represent 95% confidence intervals.
Abbreviation: r-hCG, recombinant human chorionic gonadotropin.

Figure S1 Questionnaire A.

Figure S2 Questionnaire B (days 5–6, days 7–8, and Visit 5 [end of stimulation/r-hCG administration]).

Figure S3 Questionnaire C.