drugset / Trial / NCT00702845
To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(P05690/MK-8962-001)
RandomizedParallel-groupDouble-blindTreatment
Summary
Clinical trial objectives are to investigate the efficacy and safety of a single injection of 100 μg Org 36286 in women weighing 60 kg or less to induce multifollicular development for controlled ovarian stimulation (COS), using daily recFSH as a reference.
Timeline
- Start
- 2006-12-28
- Primary completion
- 2007-07-07
- Completion
- 2007-11-15
Publications
- Results Corifollitropin alfa Ensure Study Group. Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lower-body-weight women. Reprod Biomed Online. 2010 Jul;21(1):66-76. doi: 10.1016/j.rbmo.2010.03.019. Epub 2010 Mar 28.
- Zandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.
- Griesinger G, Verweij PJ, Gates D, Devroey P, Gordon K, Stegmann BJ, Tarlatzis BC. Prediction of Ovarian Hyperstimulation Syndrome in Patients Treated with Corifollitropin alfa or rFSH in a GnRH Antagonist Protocol. PLoS One. 2016 Mar 7;11(3):e0149615. doi: 10.1371/journal.pone.0149615. eCollection 2016.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Corifollitropin alfa | Protein / enzyme biologic | 100 ug | Subcutaneous |
| Comparator | recFSH (follitropin beta) | Protein / enzyme biologic | 150 iu | Subcutaneous |
| Background | Follitropin beta | Protein / enzyme biologic | 200 iu | — |
| Background | Ganirelix | Protein / enzyme biologic | 0.25 mg | Subcutaneous |
| Background | Progesterone | Other / unclassified | 50 mg | Other |
| Background | Progesterone | Other / unclassified | 600 mg | Other |
| Background | human chorion gonadatropin (hCG) | Unknown | 5000 iu | Subcutaneous |
| Background | human chorion gonadatropin (hCG) | Unknown | 10000 iu | Subcutaneous |