A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
590
PGT-A is a technique that allows for the prediction of embryo ploidy status through analysis of a trophectoderm biopsy conducted prior to embryo transfer.
Rigshospitalet
København Ø, Denmark
RECRUITINGLive birth rate per first embryo transfer
To assess if PGT-A is superior to standard non-PGT-A treatment regarding the live birth rate per first embryo transfer (ET) (or no ET if only aneuploid embryo(s) in the PGT-A group) per randomized woman.
Time frame: Approximately 12 months after inclusion of the last patient
Cumulative live birth rate after one complete ART treatment
To assess if PGT-A is non-inferior compared to standard treatment regarding the cumulative LBR after one complete ART treatment per randomized woman.
Time frame: Approximately 18 months after inclusion of the last patient
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