Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH

Summary

The investigators propose to perform a clinical randomized trial to evaluate the effect of single embryo (blastocyst) transfer (SET) with array CGH for the evaluation of the complete chromosome complement of the blastocyst in comparison to standard ART methods in which one or more embryo are replaced. Patients will be randomized into two groups:

* Control group: patients will have up to two embryos replaced on day 5 based on morphological and developmental characteristics, and the other embryos reaching blastocyst stage will be vitrified. If patients in the control group do not have a pregnancy to term from that fresh cycle, they will be offered free PGD either for the frozen embryos of that cycle or for the next cycle (up to the center and patient). Data from that PGD is not part of the study.
* Test group: patients will have grade A,B or C blastocysts hatched on day 5, biopsied on day 5, analyzed by array CGH, and a single euploid embryo transferred on day 6. Any morulas developing to grade A,B or C blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.

Conditions

• Infertility
• Recurrent Pregnancy Loss

Interventions

GENETIC

PGD

array CGH after blastocyst biopsy

PROCEDURE

PGD

PGD using blastocyst biopsy and testing of the biopsy by array CGH

Sponsors & Collaborators

• Reprogenetics, Livingston, NJ

  collaborator UNKNOWN

• Long Island IVF, Melville, NY

  collaborator UNKNOWN

• Reproductive Associates of Illinois, Highland Park, IL

  collaborator UNKNOWN

• Yale University

  collaborator OTHER

• McGill University

  collaborator OTHER

• BlueGnome, Cambridge, UK

  collaborator UNKNOWN

• Southern California Reproductive Center, CA

  collaborator UNKNOWN

• Reprogenetics

  lead INDUSTRY

Principal Investigators

• Santiago Munne, PhD · Reprogenetics

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

32 Years

Max Age

42 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2013-12-31

Completion

2014-06-30

Countries

• United States

Study Locations