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

Summary

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.

Conditions

• Infertility

Interventions

PROCEDURE

Trophectoderm biopsy

Biopsy at blastocyst stage of trophectoderm cells for comprehensive evaluation of the eupolid status of the embryo.

PROCEDURE

Cryopreservation

Rapid freezing using vitrification

PROCEDURE

Embryo Transfer

Transfer of embryo that has been cultured in vitro into the uterus

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of California, San Francisco

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Augusta University

  collaborator OTHER

• Penn State University

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• Yale University

  lead OTHER

Principal Investigators

• Esther Eisenberg, MD · Eunice Kennedy Shriver National Institue of Child Health and Human Development

• Nanette Santoro, MD · University of Colorado, Denver

• Marcelle I Cedars, MD · University of California, San Francisco

• Christos Coutifaris, MD PhD · University of Pennsylvania

• Heping Zhang, PhD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

42 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-21

Primary Completion

2019-10-31

Completion

2019-12-31

Countries

• United States

Study Locations