The PrISICE Clinical Trial (Pre-Implantation Screening and Investigation on the Cryopreservation of Embryos)

This will be a multi-center, prospective randomized clinical trial comparing three standards
of care:

Group 1: PGS-FET group: deferred transfer of day 5/6/7 (blastocyst stage) embryos
cryopreserved following trophectoderm biopsy Group 2: "freeze-only" (FET) group: deferred
transfer of frozen/thawed embryos without biopsy Group 3: "fresh" ET group: immediate
transfer of "fresh" embryos in the stimulation cycle.

1539 eligible couples will be recruited to participate. Couples will be randomized at
retrieval to undergo cryopreservation with deferred embryo transfer, with or without PGS, or
fresh embryo transfer during the cycle of egg retrieval. Number of embryos to transfer will
be based on clinical estimation of embryo quality and will not exceed ASRM guidelines for
embryo transfer number including newly revised guidelines. We are aware that the number of
embryos transferred, to maintain enrollment, may not be equivalent, with likely more embryos
transferred in patients not having PGS. The primary outcome of live birth/retrieval, with a
secondary outcome of healthy singleton birth, may reflect the true benefit of PGS.

Inclusion Criteria:

- Scheduled to undergo in vitro fertilization for treatment of infertility (1st or 2nd
"fresh" attempt); subject can have had no more than one prior failed "fresh" IVF cycle

- Couple able to participate in a research project

- Able to understand study requirements

- Willing to sign informed consent

- Able to return for required follow-up

- Access to telephone

- Ability to read and write

- Normal uterine cavity evaluation within one year of enrollment

Exclusion Criteria:

- Medical conditions which may complicate treatment

- No plans to undergo embryo transfer

- Medical contraindication to the transfer of more than a single embryo (i.e. congenital
uterine anomaly).

- Concurrent participation in any other interventional trial

- Recurrent pregnancy loss

- Known chromosomal abnormality (e.g. translocation)

- Pre-implantation genetic diagnosis requiring blastocyst biopsy