Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH

August 20, 2013 updated by: Reprogenetics

Comparison of Standard ART Practice vs. Trophectoderm Biopsy, Array CGH Analysis, and Day-6 Replacement of a Single Euploid Embryo

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized after fertilization, and will be dropped from the study if they produce 3 or less blastocysts on day 5. The Primary efficacy endpoint of comparing the study group with the control will be (I) implantation rates and (II) multiple pregnancies (twin or higher order) comparing the first transfer.

The study may be extended to evaluate secondary efficacy endpoints which will be miscarriage rate and take home baby rates comparing the two groups.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 92677
        • Southern California Reproductive Center
    • Illinois
      • Highland Park, Illinois, United States, 60035
        • Reproductive Associates of Illinois
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Reprogenetics
    • New York
      • Melville, New York, United States, 11747
        • Long Island IVF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

32 years to 42 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Maternal age 33 to 42 years old (included)

Exclusion Criteria:

  • MESA and TESE patients
  • At least one partner carrier of a chromosomal or genetic disease
  • Abnormal ovarian reserve, defined as FSH of >10 IU/L on day 2-4 of the cycle and AMH < 1ng /ml (If only one of the two parameters altered then patients is acceptable).
  • Egg donor cycle (sperm donor is acceptable)

Exclusion criteria during stimulation:

  • Less than eight antral follicles on day 2-4 of cycle

Exclusion criteria on day 5 post retrieval:

  • Patients will be excluded if they produce less than 3 grade A,B or C blastocysts by day 5.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control - regular ART treatment
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.
EXPERIMENTAL: Test - PGD
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.
Genetic: PGD
array CGH after blastocyst biopsy
Other Names:
  • PGD: Preimplantation Genetic Diagnosis
Procedure: PGD
PGD using blastocyst biopsy and testing of the biopsy by array CGH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: First month after replacement
fetal sacs / embryos replaced
First month after replacement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spontaneous miscarriage rate
Time Frame: during first and second trimester of pregnancy
pregnancies lost / pregnancies of cycles randomized
during first and second trimester of pregnancy
ongoing pregnancy rate
Time Frame: third trimester of pregnancy
pregnancies past second trimester / cycles started
third trimester of pregnancy
Multiple pregnancy rate
Time Frame: first month after transfer
Twin or multiple order pregnancies / total pregnancies
first month after transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reprogenetics

Collaborators

McGill University
Yale University
Reprogenetics, Livingston, NJ
Long Island IVF, Melville, NY
Reproductive Associates of Illinois, Highland Park, IL
BlueGnome, Cambridge, UK
Southern California Reproductive Center, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (ESTIMATE)

March 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 20, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Reprogenetics study 389 (OTHER: Reprogenetics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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