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Prospective multicentre, non-interventional, real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study).1



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.



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.



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



  • 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



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



  1. Blockeel C et al. Front Endocrinol (Lausanne) 2022; 13:992677.

Job Code: UK-REK-2300014 - Date of preparation: July 2023


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