NCT01946945.

Study name	Comparison of Standard ART Practice vs. Trophectoderm Biopsy, Whole Chromosome Analysis by Next Generation Sequencing, and Replacement of a Single Euploid Embryo
Methods	Randomised controlled trial
Participants	Sample size: 240 Inclusion criteria: all patients medically cleared to do a fresh or frozen embryo transfer; age up to 42 years Exclusion criteria: microsurgical epididymal sperm aspiration (MESA) and testicular sperm extraction (TESE) patients; at least 1 partner carrier of a chromosomal or genetic disease; abnormal ovarian reserve, defined as follicle stimulating hormone (FSH) of > 10 IU/L on day 2 to 4 of the cycle and anti‐mullerian hormone (AMH) < 1 ng/mL (if only 1 of the 2 parameters altered, then patient is acceptable); egg donor cycle (sperm donor is acceptable); gender selection cycles, thaw cycles
Interventions	Control group: all blastocyst embryos will be biopsied on day 5/6, but the biopsies will be frozen and will not be analysed before replacement. Blastocyst embryos will be vitrified for future frozen embryo transfer (FET) cycle. Participants will have a single hatching blastocyst thawed and transferred into the uterus in an FET cycle based on standard embryo quality assessment without NGS. After transfer, all biopsied samples will be analysed (the replaced embryo also, in order to do a non‐selection study). If participants in the control group do not have a pregnancy to term from that FET cycle, euploid frozen blastocysts will be thawed and transferred on the next FET transfer. Test group: all blastocyst embryos will be biopsied on day 5/6, and the biopsies will be analysed using NGS; biopsied blastocyst embryos will be vitrified for a future FET cycle. Participants will have a single hatching euploid blastocyst thawed and transferred into the uterus in an FET cycle.
Outcomes	Primary outcome: ongoing implantation rate
Starting date	September 2013
Contact information	Allen Kung, BSc Telephone 973‐758‐7970 Email: akung@reprogenetics.com
Notes	All embryos will be biopsied, results can therefore not be taken into account in the review. First posted 20 September 2013, last updated 9 September 2014