drugset / Trial / NCT01112358

Lutropin Alfa in Women at Risk of Poor Response

NCT01112358

Phase 2 Completed 58 enrolled Merck KGaA, Darmstadt, Germany
RandomizedParallel-groupOpen-labelTreatment

Summary

Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.

Timeline

Start
2005-12-07
Primary completion
2007-01-30
Completion
2007-01-30

Publications

  • Results M.J. Fernández Ramírez, A. Monzó, T. García-Gimeno, J.M. Rubio, V. Montañana, C. Duque, G. Herrero, A. Romeu. Role of LH administration during the follicullar phase in women with risk of low response in ovarian stimulation with FSH and cetrorelix for IVF, REVISTA IBEROAMERICANA DE FERTILIDAD, Vol. 23- nº 5 - Septiembre-Octubre 2006

Drugs

EvaluationDrugModalityDoseRoute
Subject r-hLH Protein / enzyme biologic 150 iu
Background Cetrorelix Other / unclassified
Background Progesterone Other / unclassified
Background Recombinant human follicle stimulating hormone (r-hFSH) Protein / enzyme biologic 225 iu
Background Recombinant human follicle stimulating hormone (r-hFSH) Protein / enzyme biologic 450 iu
Background r-hCG Protein / enzyme biologic 250 mg Subcutaneous