drugset / Trial / NCT00749853

Efficacy of Ovarian Stimulation Based on FSHR Genotype Status

NCT00749853

Phase 3 Suspended 165 enrolled Medical University of Vienna
RandomizedParallel-groupOpen-labelTreatment

Summary

Available data from in vitro studies and clinical trials indicate that genetic factors play a significant role in the success of controlled ovarian stimulation (COS) prior to in vitro fertilization - embryo trandfer (IVF-ET). Women with the FSHR Ser680Asn Ser/Ser genotype make up between 13% and 26% of women undergoing IVF-ET and are characterised by higher basal FSH serum concentrations, the need for a higher amount of FSH for COS, and a higher risk of poor response to COS and cycle cancellation. The investigators therefore intend to perform a study to investigate whether a dose-intensified COS protocol based on FSHR genotype status in women with the FSHR Ser680Asn Ser/Ser genotype is more effective than routine management in terms of * the mean number of follicles * the mean number of embryos * the rate of poor responders * the rate of women with cycle cancellations, and v) the clinical pregnancy rates. Eligible women will be randomized to a stimulation protocol characterised by a longer duration and increased dosage of FSH stimulation (group A) or a standard stimulation protocol (group B).

Timeline

Start
2015-05
Primary completion
2015-05
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Gonal-f Protein / enzyme biologic 150 iu Subcutaneous
Subject Gonal-f Protein / enzyme biologic 450 iu Subcutaneous

Indications