ORIGINAL RESEARCH article
Front. Reprod. Health
Sec. Assisted Reproduction
Volume 7 - 2025 | doi: 10.3389/frph.2025.1650946
This article is part of the Research TopicEndocrine Regulation of Ovarian Follicle Development and Oocyte Maturation: Molecular Mechanisms and Functional InsightsView all 6 articles
A multicentric real-world observational study to describe the use and efficacy of follitropin delta for IVF/ICSI procedures in patients at risk of hypo-response
Provisionally accepted
- 1Clinique du Diaconat-Colmar, Colmar, France
- 2Institut de Medecine de la Reproduction, Marseille, France
- 3Ferring SAS, Gentilly, France
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Around 20% of patients undergoing assisted reproductive technology are at risk of hyporesponse to ovarian stimulation. The aim of this study was to describe the real-world use of follitropin delta for ovarian stimulation in these patients, as defined by POSEIDON groups 3 and 4 (an anti-Müllerian hormone (AMH) level of < 1.2 ng/mL).This study was a post-hoc analysis of participants from DELTA, a multi-centre, prospective, observational study conducted in normal care settings in fertility clinics at 14 active sites in France. A subset of 35 patients at risk of hypo-response to ovarian stimulation (mean AMH 0.7 ± 0.29 ng/mL) and treated with follitropin delta were included. Patients were followed for 10-11 weeks after the first fresh or frozen embryo transfer in case of subsequent pregnancy, and data on real-world follitropin delta use collected.Most patients (92.9%) had undergone their first IVF or ICSI. The prescribed daily dose was usually based on the approved algorithm (N = 26; 74.3%) with a mean daily dose of 14.2 ± 4.1 mcg, resulting in a mean total dose of 187.7 ± 135.6 mcg. The mean duration of ovarian stimulation was 11.6 ± 6.7 days with no premature discontinuations, while the mean number of oocytes retrieved among patients that started stimulation was 6.3 ± 4.3. A fresh transfer was performed for 21 patients (84.0%), with a mean of 1.04 ± 0.98 embryos transferred per patient.Seven patients (20.0%) achieved an ongoing pregnancy (28% per transfer). No adverse drug reactions were reported.The results describe the real-world use of follitropin delta and demonstrate its suitability for POSEIDON group 3 and 4 patients. These data complement clinical trial outcomes, supporting clinician decision-making and improving IVF/ICSI outcomes.
Keywords: ovarian hypo-response, real-word evidence, Pregnancy, ovarian stimulation / real-world evidence Follitropin Delta, follitropin delta
Received: 20 Jun 2025; Accepted: 28 Aug 2025.
Copyright: © 2025 Deloire, Porcu-Buisson, Lefebvre and Bernot. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Anne-Claire Deloire, Clinique du Diaconat-Colmar, Colmar, France
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