Clinical outcomes of three follitropin alfa preparations for ovarian stimulation using an oral micronized progesterone-primed protocol in an oocyte donation program.
| Autor: | Cruz M; IVI-RMA Global Headquarters, Madrid, Spain., Howles CM; ARIES Consulting Sàrl, Geneva, Switzerland.; Deanery of Biomedical Sciences, University of Edinburgh, Edinburgh, Scotland, United Kingdom. |
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| Jazyk: | angličtina |
| Zdroj: | Frontiers in endocrinology [Front Endocrinol (Lausanne)] 2024 Sep 27; Vol. 15, pp. 1451668. Date of Electronic Publication: 2024 Sep 27 (Print Publication: 2024). |
| DOI: | 10.3389/fendo.2024.1451668 |
| Abstrakt: | Introduction: This large multicenter study aimed to evaluate clinical outcomes using three follitropin alfa preparations within a progestin-primed ovarian stimulation (PPOS) protocol, while identifying contributing factors to cycle success. Methods: A retrospective, anonymized cohort analysis was conducted on donor-recipient cycles from 12 clinics during 2019 to 2021. 7389 oocyte donors underwent ovarian stimulation (OS) with three follitropin alfa preparations (Ovaleap ® [n=3231], Bemfola ® [n=3542], Gonal-F ® [n=616]) were included. Stimulation began on cycle days 2 or 3 with daily administration of 150-225 IU follitropin alfa. 10 mg medroxyprogesterone acetate (MPA) was administered daily until GnRH agonist trigger using a single dose of 0.2mg GnRH agonist for final follicular maturation. Statistical analysis included ANOVA, Chi-squared, and logistic regression. Results: Whilst there were some differences in patient and stimulation characteristics, including donor age and number of retrieved oocytes, clinical variables did not significantly differ among the three study groups. Linear regression revealed donor age [0.986 (0.974-0.999)] and number of mature oocytes [1.027 (1.007-1.047)] significantly impacted ongoing pregnancy rates, while the type of follitropin alfa [1.048 (0.956-1.149)] used did not. No significant differences were observed in the cumulative live birth rate (CLBR) among oocytes obtained from stimulation with Bemfola (64.9%), Gonal-F (64.1%) and Ovaleap (66.1%), p= 0.385. Discussion: This study demonstrated comparable clinical outcomes and CLBR between biosimilars and the reference product of follitropin alfa within PPOS protocols, hence they are interchangeable in a real-world patient setting. Competing Interests: Author MC was employed by company IVI-RMA Global HQ, Madrid. Author CH was employed by company ARIES Consulting Sàrl and is a consultant to Theramex HQ Ltd, London. (Copyright © 2024 Cruz and Howles.) |
| Databáze: | MEDLINE |
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