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

Abstract

Objective:

To observe the real-world utilization patterns, effectiveness and safety profile of follitropin delta in women ≥18 years naïve to ovarian stimulation undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Design:

Prospective, multinational, multicenter, observational study. All IVF/ICSI treatment protocols were conducted according to routine clinical practice, including undertaking fresh/frozen transfers. Outcomes included use of dosing algorithm, follitropin delta dosing patterns, ovarian response, pregnancy rates and adverse drug reactions (ADRs).

Results:

The first ovarian stimulation cycle using follitropin delta was initiated in 944 women. Mean baseline demographics were: age, 33.5 ± 4.7 years; bodyweight, 67.1 ± 13.6 kg; anti-Müllerian hormone, 20.3 ± 16.1 pmol/L (2.84 ± 2.25 ng/mL). The dosing algorithm was used to calculate the follitropin delta daily starting dose in 893/944 women (94.5%). The mean difference between the calculated and prescribed daily dose was small (0.2 ± 1.40 µg). The mean daily starting follitropin delta dose was 10.4 ± 2.72 µg and the mean total dose administered was 104 µg. Follitropin delta dose adjustments were reported for 57/944 (6.0%) women. The mean number of retrieved oocytes was 10.1 ± 7.03. Ongoing pregnancy at 10-11 weeks was reported for 255 women (27.0% per initiated cycle and 43.1% per fresh transfer [n=592]). Cumulative ongoing pregnancy rate after fresh and/or frozen transfer was 36.4% (344/944). Four women discontinued follitropin delta due to ADRs. Ovarian hyperstimulation syndrome (OHSS) was the most frequently reported ADR (n=37 [3.9%]); most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]).

Conclusions:

This large real-world study of follitropin delta utilization patterns confirms its good pregnancy rates while minimizing OHSS risk during first ovarian stimulation cycle.

• Authors: Christophe Blockeel, Georg Griesinger, Rocco Rago, Per Larsson, Yum Lina Yip Sonderegger, Stéphane Rivière, Joop S E Laven
• Journal: Frontiers in endocrinology (Front Endocrinol (Lausanne)) Vol. 13 Pg. 992677 ( 2022) ISSN: 1664-2392 [Print] Switzerland
• PMID: 36619578 (Publication Type: Observational Study, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2022 Blockeel, Griesinger, Rago, Larsson, Sonderegger, Rivière and Laven.

Chemical References

• follitropin delta
• Follicle Stimulating Hormone, Human
• Follicle Stimulating Hormone

Topics

• Pregnancy
• Humans
• Male
• Female
• Prospective Studies
• Semen
• Follicle Stimulating Hormone, Human (adverse effects)
• Fertilization in Vitro (methods)
• Ovarian Hyperstimulation Syndrome (chemically induced)
• Follicle Stimulating Hormone