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



Status:Recruiting
Conditions:Women's Studies, Infertility
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 42
Updated:10/21/2018
Start Date:August 21, 2018
End Date:August 31, 2019

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A Prospective, Randomized, Controlled Clinical Trial Evaluating the Superiority of Preimplantation Genetic Screening (PGS) and Deferred Transfer of Cryopreserved Embryos Over "Freeze-Only" Deferred Transfer Without PGS or Immediate Embryo Transfer During a "Fresh" In Vitro Fertilization Cycle

The trial objective is to determine whether the deferred transfer of embryos following
cryopreservation at the blastocyst stage following pre-implantation genetic screening
(PGS-FET) improves live birthrates compared to both the deferred transfer of cryopreserved
embryos without PGS (FET) and immediate transfer at the conclusion of a "fresh" in vitro
fertilization (IVF) cycle (Fresh). Additionally, whether "freeze-only" (FET) improves live
birth rates compared to "fresh" will be determined.

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
We found this trial at
3
sites
1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Karl Hansen, MD, PhD
Phone: 405-271-1616
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Christos Coutifaris, MD, PhD
Phone: 215-349-5201
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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San Francisco, California 94143
Principal Investigator: Marcelle Cedars, MD
Phone: 415-353-4305
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San Francisco, CA
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