drugset / Trial / NCT02466204

Efficacy of Corifollitropin Alfa Versus Follitropin Beta in Aged IVF (In-vitro Fertilization) Patients

NCT02466204

RandomizedParallel-groupOpen-labelTreatment

Summary

A prospective, randomized, controlled study to explore the efficacy and safety of using either corifollitropin alfa 150 mcg or daily recombinant follicle stimulation hormone (FSH) 300 international unit (IU) for the stimulation treatment of subjects undergoing controlled ovarian stimulation prior to IVF. The study is designed as a non-inferiority trial. The sample size for this trial of 400 subjects, in both groups, being treated for one IVF cycle is based upon the primary endpoint of the number of oocytes retrieved.

Timeline

Start
2015-06-01
Primary completion
2016-08-10
Completion
2017-08-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Corifollitropin alfa Protein / enzyme biologic 150 ug Subcutaneous
Comparator Follitropin beta Protein / enzyme biologic 300 iu Subcutaneous

Indications