drugset / Trial / NCT01426386
A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
RandomizedParallel-groupSingle-blindTreatment
Summary
This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.
Timeline
- Start
- 2011-09
- Primary completion
- 2012-04
- Completion
- 2013-03
Outcome
Met primary endpoint
registry p <0.001; Slope of the dose-response curve 7.9 (95% CI 5.69 to 10.18); ANCOVA NCT01426386 ↗
paper The number of oocytes retrieved increased in an rhFSH dose-dependent manner PMID 25256937 ↗
Publications
- Results Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.
- Arce JC, Andersen AN, Fernandez-Sanchez M, Visnova H, Bosch E, Garcia-Velasco JA, Barri P, de Sutter P, Klein BM, Fauser BC. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone-stratified, dose-response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633-40.e5. doi: 10.1016/j.fertnstert.2014.08.013. Epub 2014 Sep 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Follitropin delta | Protein / enzyme biologic | 5.2 ug | — |
| Subject | Follitropin delta | Protein / enzyme biologic | 6.9 ug | — |
| Subject | Follitropin delta | Protein / enzyme biologic | 8.6 ug | — |
| Subject | Follitropin delta | Protein / enzyme biologic | 10.3 ug | — |
| Subject | Follitropin delta | Protein / enzyme biologic | 12.1 ug | — |
| Comparator | Gonal-f | Protein / enzyme biologic | 11 ug | — |