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. 2023 May 16;21(1):45.
doi: 10.1186/s12958-023-01090-w.

Live birth rates following individualized dosing algorithm of follitropin delta in a long GnRH agonist protocol

Manuel Fernández Sánchez  1   2   3   4 , Per Larsson  5 , Marcos Ferrando Serrano  6   7 , Ernesto Bosch  6   8 , Juan Antonio García Velasco  6   9 , Esther Santamaría López  10   6 , Bernadette Mannaerts  11
Affiliations

Live birth rates following individualized dosing algorithm of follitropin delta in a long GnRH agonist protocol

Manuel Fernández Sánchez et al. Reprod Biol Endocrinol. .

Abstract

Purpose: To explore the efficacy and safety of individualized follitropin delta dosing, based on serum anti-Müllerian hormone (AMH) concentration and bodyweight, in a long gonadotropin-releasing hormone (GnRH) agonist protocol.

Methods: Clinical outcomes after one treatment cycle are reported in women with AMH: 5-35 pmol/L. Oocytes were inseminated by intracytoplasmic sperm injection, blastocyst transfer was on Day 5 and remaining blastocysts were cryopreserved. Data collection included live births and neonatal health follow-up for all fresh/frozen transfers performed within one year after treatment allocation.

Results: In total, 104 women started stimulation, of whom 101 had oocyte recovery and 92 had blastocyst transfer. The average daily dose of follitropin delta was 11.0 ± 1.6 µg and the duration of stimulation was 10.3 ± 1.6 days. The mean number of oocytes was 12.5 ± 6.4, the mean number of blastocysts was 5.1 ± 3.4, and 85% had at least one good-quality blastocyst. Following mostly single blastocyst transfer (95%), the ongoing pregnancy rate was 43%, the live-birth rate was 43%, and the cumulative live-birth rate was 58% per started stimulation. There were 6 cases of early OHSS (5.8%) graded as mild (n = 3) and moderate (n = 3) and 6 cases of late OHSS (5.8%) graded as moderate (n = 3) and severe (n = 3).

Conclusion: In this first evaluation of the individualized follitropin delta dosing in a long GnRH agonist protocol, the cumulative live-birth rate was high. A randomized trial comparing follitropin delta in a long GnRH agonist protocol versus in a GnRH antagonist protocol should provide further insight into the efficacy and safety of this treatment option.

Trial registration number: NCT03564509; June 21, 2018.

Keywords: Cumulative live birth rates; Follitropin delta; Individualized dosing; Long GnRH agonist.

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Conflict of interest statement

M.F.S. has received grants and/or speaker fees from Ferring, Merck, Organon, MSD, Gedeon Richter, Theramex, IBSA. P.L. is an employee of Ferring Pharmaceuticals. M.F. has received consulting fees from Gedon Richter, speaker fees from Merck, MDS, Gedeon Richter and Ferring Pharmaceuticals, and has received support for attending meetings and/or travel from Ferring Pharmaceuticals, Merck, MSD, Gedeon Richter, IBSA, and Theramex. E.B. has received research funding from Roche Diagnostics and IBSA, a grant from Gedeon-Richter, speaker fees from Ferring Pharmaceticals, Merck, MSD, Gedeon-Richter, Roche Diagnostics and IBSA, and has participated in data safety monitoring/advisory board for Ferring Pharmaceuticals, Merck, MSD, Gedeon-Richter Roche Diagnostics, IBSA, and Abbott. J.A.G.V. has received grants and/or speaker fees from Ferring, Merck, Organon, MSD, Gedeon Richter, Theramex and IBSA. E.S.L. has no completing interests. B.M. was an employee of Ferring Pharmaceuticals at the time of the study.

Figures

Fig. 1
Fig. 1
All fresh and cryopreserved transfers, and live births, versus time from start of stimulation. Digits represent the order of the transfers, with 1 being the first transfer (fresh, or the first cryopreserved for subjects without fresh transfer), and 2 being the second transfer (cryopreserved), etc. The subjects are sorted by time to first live birth, and shown as percent of all subjects, so that the live birth digits form a cumulative live birth rate vs. time curve
Fig. 2
Fig. 2
Cumulative live birth rate versus time from start of stimulation. Following fresh blastocyst transfer, 43.3% of women had live birth and following cryopreserved transfers the live birth rate further increased to 57.7% (both at birth and 4 weeks after birth)
See this image and copyright information in PMC

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