drugset / Trial / NCT03296527
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women
RandomizedParallel-groupDouble-blindTreatment
Summary
To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.
Timeline
- Start
- 2017-12-01
- Primary completion
- 2020-01-03
- Completion
- 2020-07-26
Publications
- Results Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, Goethberg M, Mannaerts B, Arce JC. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Aug 18;36(9):2452-2462. doi: 10.1093/humrep/deab155.
- Results Yang R, Zhang Y, Liang X, Song X, Wei Z, Liu J, Yang Y, Tan J, Zhang Q, Sun Y, Wang W, Qian W, Jin L, Wang S, Xu Y, Yang J, Goethberg M, Mannaerts B, Wu W, Zheng Z, Qiao J. Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization /intracytoplasmic sperm injection. Reprod Biol Endocrinol. 2022 Oct 4;20(1):147. doi: 10.1186/s12958-022-01016-y.
- 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 |
|---|---|---|---|---|
| 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 | 12 ug | Subcutaneous |
| Comparator | Gonal-f | Protein / enzyme biologic | 150 iu | Subcutaneous |
Indications
No indication recorded.