Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH
This study is currently recruiting participants.
Verified March 2012 by Reprogenetics
Sponsor:
Reprogenetics
Collaborators:
Reprogenetics, Livingston, NJ
Main Line Fertility and Reproductive Medicine, Bryn Mawr, PA
Boston IVF, Waltham, MA
Long Island IVF, Melville, NY
Reproductive Associates of Illinois, Highland Park, IL
Yale University
McGill University
BlueGnome, Cambridge, UK
Information provided by (Responsible Party):
Reprogenetics
ClinicalTrials.gov Identifier:
NCT01546350
First received: March 2, 2012
Last updated: March 10, 2012
Last verified: March 2012
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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: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546350
Locations
| United States, Illinois | |
| Reproductive Associates of Illinois | Recruiting |
| Highland Park, Illinois, United States, 60035 | |
| Contact: Ilynne McGovern 847-266-3535 Ilynne.mcgovern@integramed.com | |
| Contact: Kim Wagner (847) 2663535 kim.wagner@integramed.com | |
| Principal Investigator: Coleen Wagner, PhD | |
| United States, Massachusetts | |
| Boston IVF | Recruiting |
| Waltham, Massachusetts, United States, 02451 | |
| Contact: Kim Thornton, MD 781-434-6470 kim.Thornton@bostonivf.com | |
| Contact: Kristin Rooney, MD 781-434-6470 kristin.rooney@bostonivf.com | |
| Principal Investigator: Kim Thornton, MD | |
| United States, New Jersey | |
| Reprogenetics | Active, not recruiting |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| Long Island IVF | Recruiting |
| Melville, New York, United States, 11747 | |
| Contact: Daniel Keningsberg, MD 631-752-0606 drkenigsberg@liivf.com | |
| Principal Investigator: Daniel Kenigsberg, MD | |
| United States, Pennsylvania | |
| Main Line Fertility and Reproductive Medicine | Recruiting |
| Bryn Mawr, Pennsylvania, United States, 19010 | |
| Contact: Eileen B Davies 484-337-8955 daviese@mainlinefertility.com | |
| Contact: Sharon Anderson, PhD (610) 527-0800 andes@early.com | |
| Principal Investigator: Sharon Anderson, PhD | |
Sponsors and Collaborators
Reprogenetics
Reprogenetics, Livingston, NJ
Main Line Fertility and Reproductive Medicine, Bryn Mawr, PA
Boston IVF, Waltham, MA
Long Island IVF, Melville, NY
Reproductive Associates of Illinois, Highland Park, IL
Yale University
McGill University
BlueGnome, Cambridge, UK
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: | March 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Reprogenetics:
|
infertility, recurrent pregnancy loss, miscarriage |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 19, 2013