Objective: To observe the real-world utilization patterns, effectiveness and safety profile of follitropin delta in women ≥18 years naïve to ovarian stimulation undergoing 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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9815701 | PMC |
| http://dx.doi.org/10.3389/fendo.2022.992677 | DOI Listing |
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Article Synopsis
- - The study focused on optimising controlled ovarian stimulation (COS) for IVF by personalising treatment plans based on individual patient factors like medical history and ovarian reserve.
- - Researchers implemented a protocol using a novel hormone, follitropin delta, in combination with human menotrophin (HP-hMG) and tailored doses for 20 patients, evaluating outcomes such as clinical pregnancy rate (CPR).
- - Results showed a high CPR of 70% per started cycle, with no cycle cancellations or safety issues like ovarian hyperstimulation syndrome, indicating a promising risk-benefit balance for this mixed protocol in IVF.
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