drugset / Trial / NCT01210144

EXpression PRofile Endometrium Samples Study

NCT01210144

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest. The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.

Timeline

Start
2008-08
Primary completion
2010-08
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Gonal-f Protein / enzyme biologic 150 iu
Background Ovidrel Protein / enzyme biologic 250 ug

Indications

No indication recorded.