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In the registrational trials, follitropin delta was compared with a fixed dose of 150 UI of follitropin alpha/beta, finding higher chances to reach a target response of 8-14 oocytes compared to controls. For this reason, follitropin delta is marketed as particularly useful in expected hyper-responder patients. The main outcome of this study is to report if comparable results are reached in a real-life scenario with follitropin alpha/beta personalized doses, based on patients' characteristics. This is a retrospective study performed in two public fertility centres. All first cycles from January 2020 to June 2022 with either follitropin delta (cases) or alpha/beta (controls) in patients with antiMüllerian hormone >2.5 ng/ml were compared by an inverse probability weighting approach based on propensity score. The follitropin total dose was higher in controls (1179.06 ± 344.93 vs. 1668.67 ± 555.22 IU, p<0.001). The target response of 8-14 oocytes was reached by 40.2% of cases and 40.7% of controls (odds ratio (OR) 0.99, 95% confidence interval (CI) 0.65-1.53, p=0.98). Fewer than 8 oocytes were collected in 24.1% of cases and 22% of controls (OR 1.10, 95% CI 0.71-1.69, p=0.67); more than 14 oocytes in 35.7% of cases and 37.3% of controls (OR 0.83, 95% CI 0.54-1.28, p=0.40). Our experience did not find worse results in term of proportion of patients who reached the target response with an algorithm-chosen dose of follitropin delta compared to a personalised starting dose of follitropin alpha/beta, with follitropin delta having the advantage of objectivity. Larger numbers are needed to confirm these results.
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http://dx.doi.org/10.1530/RAF-23-0045 | DOI Listing |
Minerva Obstet Gynecol
September 2025
Baylor Scott & White Health, Department of Obstetrics and Gynecology, Temple, TX, USA.
Background: Different gonadotropins (Gn) have been developed to stimulate the ovaries as part of in-vitro fertilization (IVF). Studies comparing these formulations in poor responders are limited. The objective of this study was to evaluate clinical outcomes comparing follitropin-δ to follitropin-α in expected poor responders.
View Article and Find Full Text PDFBioDrugs
September 2025
Department of Pharmacy, Faculty of Pharmacy, Uppsala University, Box 580, 751 23, Uppsala, Sweden.
Background And Objectives: Biopharmaceuticals add value in the treatment of many diseases but different health systems in Europe face clinical and economic challenges with introducing them. Joint efforts across Europe are therefore essential to ensure their sustainable and equitable use. However, to date few cross-national comparative studies have assessed their introduction.
View Article and Find Full Text PDFClin Pharmacol Ther
July 2025
School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Understanding the variability in ovarian response following administration of follicle-stimulating hormone medications in women undergoing in vitro fertilization may help inform prescribing decisions. A systematic review was conducted to compare the number of retrieved oocytes and fertility outcomes following the administration of different follicle-stimulating hormone medications. Databases were searched from inception to November 2024, including studies that compared two follicle-stimulating hormone medications, including follitropin alfa, follitropin beta, follitropin delta, and urofollitropin.
View Article and Find Full Text PDFFertil Steril
July 2025
Clinical Development and Medical Scientific Affairs, Ferring Pharmaceuticals Inc., Parsippany, New Jersey.
Objective: To demonstrate the efficacy and safety of follitropin delta (recombinant follicle-stimulating hormone produced from the human cell line PER.C6) for ovarian stimulation in patients aged 18-34 and 35-42 years undergoing in vitro fertilization or intracytoplasmic sperm injection treatment in the United States.
Design: Two randomized, double-blind, placebo-controlled, parallel-group, multicenter trials (RITA-1 and RITA-2).
Hum Reprod
September 2025
Global Research and Medical, Ferring Pharmaceuticals, Kastrup, Denmark.
Study Question: How do ovarian responses using conventional dosing for follitropin delta 15 µg/day compare with follitropin alfa 225 IU/day in women undergoing ovarian stimulation?
Summary Answer: The ADAPT-1 trial demonstrates similar ovarian responses with follitropin delta 15 µg/day and follitropin alfa 225 IU/day starting doses in a conventional dosing regimen.
What Is Known Already: Follitropin delta, a recombinant FSH (rFSH), is currently approved for ovarian stimulation using an individualized fixed daily dose based on serum anti-Müllerian hormone (AMH) and bodyweight (maximum 12 µg/day for first cycle and 24 µg/day in subsequent cycles). Other rFSHs, such as follitropin alfa, conventionally apply a starting dose of 150-225 IU, fixed for the initial days of stimulation, after which dose adjustments can be made (maximum 450 IU/day).