drugset / Trial / NCT01956110
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1
RandomizedParallel-groupSingle-blindTreatment
Summary
This trial investigates the effects of FE 999049 compared to GONAL-F.
Timeline
- Start
- 2013-10
- Primary completion
- 2015-05
- Completion
- 2017-01-03
Outcome
Met primary endpoint
paper Ongoing pregnancy (30.7% vs. 31.6%; difference -0.9% [95% confidence interval (CI) -5.9% to 4.1%]) PMID 27912901 ↗
paper ongoing implantation (35.2% vs. 35.8%; -0.6% [95% CI -6.1% to 4.8%]) PMID 27912901 ↗
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.
- Results Havelock J, Aaris Henningsen AK, Mannaerts B, Arce JC; ESTHER-1 and ESTHER-2 Trial Groups. Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta. J Assist Reprod Genet. 2021 Oct;38(10):2651-2661. doi: 10.1007/s10815-021-02271-5. Epub 2021 Jul 13.
- 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.
- Nelson SM, Larsson P, Mannaerts BMJL, Nyboe Andersen A, Fauser BCJM. Anti-Mullerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta. Clin Endocrinol (Oxf). 2019 May;90(5):719-726. doi: 10.1111/cen.13956. Epub 2019 Mar 18.
- Nyboe Andersen A, Nelson SM, Fauser BC, Garcia-Velasco JA, Klein BM, Arce JC; ESTHER-1 study group. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 Feb;107(2):387-396.e4. doi: 10.1016/j.fertnstert.2016.10.033. Epub 2016 Nov 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Follitropin delta | Protein / enzyme biologic | 0.1 ug/kg | — |
| Subject | Follitropin delta | Protein / enzyme biologic | 0.19 ug/kg | — |
| Subject | Follitropin delta | Protein / enzyme biologic | 12 ug | — |
| Comparator | Gonal-f | Protein / enzyme biologic | 150 iu | — |