drugset / Trial / NCT03228680
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women
RandomizedParallel-groupDouble-blindTreatment
Summary
To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.
Timeline
- Start
- 2017-07-29
- Primary completion
- 2019-06-10
- Completion
- 2019-07-08
Publications
- Results Ishihara O, Arce JC; Japanese Follitropin Delta Phase 3 Trial (STORK) Group. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-918. doi: 10.1016/j.rbmo.2021.01.023. Epub 2021 Feb 9.
- Results Ishihara O, Nelson SM, Arce JC. Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients. Reprod Biomed Online. 2022 Jan;44(1):177-184. doi: 10.1016/j.rbmo.2021.09.014. Epub 2021 Sep 23.
- Results Fernandez-Sanchez M, Fatemi H, Garcia-Velasco JA, Heiser PW, Daftary GS, Mannaerts B. Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach. Gynecol Endocrinol. 2023 Dec;39(1):2205952. doi: 10.1080/09513590.2023.2205952.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Follitropin beta | Protein / enzyme biologic | 150 iu | Subcutaneous |
| Comparator | Follitropin beta | Protein / enzyme biologic | 375 iu | Subcutaneous |
| Subject | Follitropin delta | Protein / enzyme biologic | 0.1 ug/kg | Subcutaneous |
| Subject | Follitropin delta | Protein / enzyme biologic | 0.19 ug/kg | Subcutaneous |
| Subject | Follitropin delta | Protein / enzyme biologic | 6 ug | Subcutaneous |
| Subject | Follitropin delta | Protein / enzyme biologic | 12 ug | Subcutaneous |