drugset
drugset / Trial / NCT01071200

Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle

NCT01071200 ↗

Phase 3 Terminated 133 enrolled Merck KGaA, Darmstadt, Germany Merck Serono S.P.A., Italy · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The present study was designed to investigate, in hyporesponder subjects, that required in a previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH) \>3500 International Unit (IU), the possibility to decrease through recombinant human luteinizing hormone (r-hLH) supplementation, the FSH amount per oocytes retrieved and in the mean time to improve the overall cycle outcome.

Timeline

Start
2005-03
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Gonal-f Protein / enzyme biologic — Subcutaneous
Subject Recombinant Human Luteinizing Hormone Protein / enzyme biologic — Subcutaneous

Indications

No indication recorded.