Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)

Phase 3 Completed 437 enrolled Ferring Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the efficacy and safety of FE 999049 (follitropin delta) and its personalized dosing algorithm in controlled ovarian stimulation for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) using a long gonadotropin-releasing hormone (GnRH) agonist protocol versus a short GnRH antagonist protocol.

Timeline

Start: 2019-04-29
Primary completion: 2022-02-16
Completion: 2022-02-16

Outcome

Met primary endpoint

paper The mean number of oocytes retrieved was statistically significantly higher in the agonist group (11.1 ± 5.9) versus the antagonist group (9.6 ± 5.5) PMID 38723189 ↗

paper with an estimated mean difference of 1.31 oocytes (95% CI: 0.22; 2.40, P = 0.0185). PMID 38723189 ↗

Publications

Lobo R, Soerdal T, Ekerhovd E, Cohlen B, Porcu E, Schenk M, Shufaro Y, Smeenk J, Suerdieck MB, Pinton P, Pinborg A; BEYOND Investigators. BEYOND: a randomized controlled trial comparing efficacy and safety of individualized follitropin delta dosing in a GnRH agonist versus antagonist protocol during the first ovarian stimulation cycle. Hum Reprod. 2024 May 9;39(7):1481-94. doi: 10.1093/humrep/deae092. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cetrorelix	Other / unclassified	—	—
Subject	Follitropin delta	Protein / enzyme biologic	—	—
Subject	Gonapeptyl	Unknown	—	—