drugset / Trial / NCT00598208
A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian (Study 38826)(P06055)(COMPLETED)
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.
Timeline
- Start
- 2003-05-19
- Primary completion
- 2004-03-15
- Completion
- 2004-03-15
Outcome
Met primary endpoint
paper The number of cumulus-oocyte complexes retrieved showed a clear dose-response relationship (P < 0.0001) PMID 18684735 ↗
paper A single injection of corifollitropin alfa induces dose-related increase in multifollicular development and in the number of retrieved oocytes. PMID 18684735 ↗
Publications
- 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.
- Corifollitropin Alfa Dose-finding Study Group. A randomized dose-response trial of a single injection of corifollitropin alfa to sustain multifollicular growth during controlled ovarian stimulation. Hum Reprod. 2008 Nov;23(11):2484-92. doi: 10.1093/humrep/den288. Epub 2008 Aug 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Corifollitropin alfa | Protein / enzyme biologic | 60 ug | — |
| Subject | Corifollitropin alfa | Protein / enzyme biologic | 120 ug | — |
| Subject | Corifollitropin alfa | Protein / enzyme biologic | 180 ug | — |
| Comparator | Follitropin beta injection | Protein / enzyme biologic | 150 iu | Subcutaneous |
Indications
No indication recorded.