Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH

This study has suspended participant recruitment.
(not enough patients recruited on time)
Sponsor:
Collaborators:
Reprogenetics, Livingston, NJ
Long Island IVF, Melville, NY
Reproductive Associates of Illinois, Highland Park, IL
Yale University
McGill University
BlueGnome, Cambridge, UK
Southern California Reproductive Center, CA
Information provided by (Responsible Party):
Reprogenetics
ClinicalTrials.gov Identifier:
NCT01546350
First received: March 2, 2012
Last updated: August 20, 2013
Last verified: May 2013
  Purpose

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.

Condition Intervention Phase
Infertility
Recurrent Pregnancy Loss
Genetic: PGD
Procedure: PGD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Comparison of Standard ART Practice vs. Trophectoderm Biopsy, Array CGH Analysis, and Day-6 Replacement of a Single Euploid Embryo

Resource links provided by NLM:


Further study details as provided by Reprogenetics:

Primary Outcome Measures:
  • Implantation rate [ Time Frame: First month after replacement ] [ Designated as safety issue: No ]
    fetal sacs / embryos replaced


Secondary Outcome Measures:
  • Spontaneous miscarriage rate [ Time Frame: during first and second trimester of pregnancy ] [ Designated as safety issue: Yes ]
    pregnancies lost / pregnancies of cycles randomized

  • ongoing pregnancy rate [ Time Frame: third trimester of pregnancy ] [ Designated as safety issue: No ]
    pregnancies past second trimester / cycles started

  • Multiple pregnancy rate [ Time Frame: first month after transfer ] [ Designated as safety issue: Yes ]
    Twin or multiple order pregnancies / total pregnancies


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PGD: Preimplantation Genetic Diagnosis
Procedure: PGD
PGD using blastocyst biopsy and testing of the biopsy by array CGH

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.

  Eligibility

Ages Eligible for Study:   32 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546350

Locations
United States, California
Southern California Reproductive Center
Beverly Hills, California, United States, 92677
United States, Illinois
Reproductive Associates of Illinois
Highland Park, Illinois, United States, 60035
United States, New Jersey
Reprogenetics
Livingston, New Jersey, United States, 07039
United States, New York
Long Island IVF
Melville, New York, United States, 11747
Sponsors and Collaborators
Reprogenetics
Reprogenetics, Livingston, NJ
Long Island IVF, Melville, NY
Reproductive Associates of Illinois, Highland Park, IL
Yale University
McGill University
BlueGnome, Cambridge, UK
Southern California Reproductive Center, CA
Investigators
Study Director: Santiago Munne, PhD Reprogenetics
  More Information

Publications:
Responsible Party: Reprogenetics
ClinicalTrials.gov Identifier: NCT01546350     History of Changes
Other Study ID Numbers: Reprogenetics study 389, Reprogenetics study 389
Study First Received: March 2, 2012
Last Updated: August 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Reprogenetics:
infertility, recurrent pregnancy loss, miscarriage

Additional relevant MeSH terms:
Infertility
Fetal Death
Genital Diseases, Male
Genital Diseases, Female
Pregnancy Complications
Death
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014