OBJECTIVE

To examine the usage patterns, effectiveness and safety of follitropin delta in real-world clinical practice involving women aged at least 18 years receiving ovarian stimulation (OS) for their first in vitro fertilisation (IVF) / intracytoplasmic sperm injection (ICSI) treatment.

DESIGN

PROFILE was a prospective, multinational, multicentre, observational study of women undergoing OS for IVF/ICSI. All IVF/ICSI procedures were conducted according to routine clinical practice, including undertaking fresh/frozen transfers. The patient study flow is outline in Figure 1.

• The primary outcomes included follitropin delta usage patterns, including starting daily dose, duration of treatment, and use of other treatments during OS
• Secondary outcomes included ovarian response in Cycle 1, pregnancy rates, cancellation rates for Cycle 1, and adverse drug reactions (ADRs) including ovarian hyperstimulation syndrome (OHSS)

Figure 1: Patient study flow

*Patient follow up was truncated at the global cut off date of 02 October 2020.

Adapted from Blockeel C et al. 2022.

RESULTS

944 women were identified as having initiated their first OS cycle using follitropin delta. Mean demographics of the population were: age, 33.5 ± 4.7 years; bodyweight, 67.1 ± 13.6 kg; and AMH levels, 20.3 ± 16.1 pmol/L (2.84 ± 2.25 ng/mL).

KEY PRIMARY OUTCOMES – real-world follitropin delta treatment patterns

• Dosing: The mean daily starting dose was 10.4 ± 2.72 μg and the mean total dose administered was 104 μg
• Duration of treatment: The median duration of treatment was 10.0 ± 2.25 days

KEY SECONDARY OUTCOMES

• Ongoing pregnancy: At 10–11 weeks after fresh transfer, ongoing pregnancies were reported for 27.0% (255/944) of women
• Cumulative ongoing-pregnancy rate in patients with at least one transfer (fresh and/or frozen transfer) was 36.4% (344/944)
• Oocyte retrieval: The mean number of oocytes retrieved in Cycle 1 was 10.1 ± 7.03 oocytes
• Safety: OHSS was reported in 3.9% (37/944) of women. Most reported cases of OHSS were graded as mild-to-moderate intensity (3.2%, 30/944)
  • Seven women (0.7%) had severe OHSS
  • Nine women were hospitalised due to OHSS (median 6.0 days duration)
  • 16.5% (156/944) of women received preventive interventions for potential early OHSS
  • All women recovered from their OHSS with no sequalae
• Discontinuations: Cycle 1 was cancelled in 18.7% (177/944) of women. The most common reason for cancellation before oocyte collection was poor ovarian response (3.5%, 32/944). Discontinuation of follitropin delta due to ADRs occurred in 0.4% (4/944) of women

CONCLUSION

Evidence from the PROFILE study of real-world follitropin delta usage supports pregnancy rates observed in the randomised, controlled trials (RCTs) for follitropin delta, and a similar proportion of women experienced any OHSS in PROFILE compared with RCTs for follitropin delta.

• PROFILE demonstrates that the follitropin delta dosing algorithm allows for acceptable ovarian responses and ongoing pregnancy rates at least comparable to those observed in clinical trials

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