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ORIGINAL RESEARCH article

Front. Endocrinol.
Sec. Reproduction
Volume 15 - 2024 | doi: 10.3389/fendo.2024.1451668

Clinical outcomes of three follitropin alfa preparations for ovarian stimulation using an oral micronized progesterone-primed protocol in an oocyte donation program

Provisionally accepted
COLIN M. HOWLES COLIN M. HOWLES 1,2*María Cruz María Cruz 3
  • 1 ARIES Consulting, Consultant, Geneva, Switzerland
  • 2 Centre for Biomedicine, Self and Society, Usher Institute, Edinburgh Medical School, University of Edinburgh, Edinburgh, United Kingdom
  • 3 IVI Madrid - Clínica de Reproducción Asistida y Fertilidad (IVIRMA), Madrid, Catalonia, Spain

The final, formatted version of the article will be published soon.

    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. A retrospective, anonymized cohort analysis was conducted on donor-recipient cycles from 12 clinics during 2019 to 2021. A total of 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. Additionally, 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. While there were some differences in patient and stimulation characteristics, including donor age and the number of retrieved oocytes, the 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. This study demonstrated comparable clinical outcomes and CLBR between biosimilars and the reference product of follitropin alfa within PPOS protocols, indicating that they are interchangeable in a real-world patient setting.

    Keywords: Follitropin alfa, Medroxyprogesterone Acetate, FSH biosimilar, ovarian stimulation, Oocyte Donation, Ongoing pregnancy rate, cumulative live birth rate

    Received: 19 Jun 2024; Accepted: 09 Sep 2024.

    Copyright: © 2024 HOWLES and Cruz. 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: COLIN M. HOWLES, ARIES Consulting, Consultant, Geneva, Switzerland

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.