drugset / Trial / NCT01636505

The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol

NCT01636505

Phase 3 Unknown 200 enrolled European Hospital
RandomizedParallel-groupOpen-labelScreening

Summary

The aim of this study is to performed a randomized controlled trial to evaluate the rate of genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocols. Patients will be prospectively randomized in two groups: the first undergoing controlled ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist ovarian stimulation regimen. The end-points of the study include the number of genetically and chromosomally abnormal embryos, the pregnancy, the implantation and the healthy baby birth rate. The patients included in PGS program were selected on the base of advanced maternal age, repeated pregnancy lost and implantation failure whereas the patients who were know to carry sex-linked or monogenic disorders were considered for PGD strategy. The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the exclusion factors.

Timeline

Start
2012-09
Primary completion
2013-02
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cetrorelix Other / unclassified 0.25 mg
Comparator Ganirelix Protein / enzyme biologic 0.25 mg
Comparator suprefact Unknown 5.5 ml

Indications

No indication recorded.