drugset / Trial / NCT00249834
Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.
Timeline
- Start
- 2004-09-22
- Primary completion
- 2006-01-16
- Completion
- 2006-01-16
Publications
- Background Olivennes F, Howles CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V; CONSORT study group. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2009 Feb;18(2):195-204. doi: 10.1016/s1472-6483(10)60256-8.
- Results Olivennes F, Howies CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S73-82. doi: 10.1016/S1472-6483(11)60012-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gonal-f | Protein / enzyme biologic | 37.5 iu | Subcutaneous |
| Subject | Gonal-f | Protein / enzyme biologic | 75 iu | Subcutaneous |
| Subject | Gonal-f | Protein / enzyme biologic | 112.5 iu | Subcutaneous |
| Subject | Gonal-f | Protein / enzyme biologic | 150 iu | Subcutaneous |
| Subject | Gonal-f | Protein / enzyme biologic | 187.5 iu | Subcutaneous |
| Subject | Gonal-f | Protein / enzyme biologic | 225 iu | Subcutaneous |
| Subject | Gonal-f | Protein / enzyme biologic | 262.5 iu | Subcutaneous |
| Subject | Gonal-f | Protein / enzyme biologic | 300 iu | Subcutaneous |
| Background | Ovidrel | Protein / enzyme biologic | 250 ug | — |