Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH
NCT ID: NCT01546350
Last Updated: 2013-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
200 participants
INTERVENTIONAL
2012-03-31
2014-06-30
Brief Summary
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* 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.
Detailed Description
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The study may be extended to evaluate secondary efficacy endpoints which will be miscarriage rate and take home baby rates comparing the two groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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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.
No interventions assigned to this group
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.
PGD
array CGH after blastocyst biopsy
PGD
PGD using blastocyst biopsy and testing of the biopsy by array CGH
Interventions
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PGD
array CGH after blastocyst biopsy
PGD
PGD using blastocyst biopsy and testing of the biopsy by array CGH
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
* Less than eight antral follicles on day 2-4 of cycle
* Patients will be excluded if they produce less than 3 grade A,B or C blastocysts by day 5.
32 Years
42 Years
FEMALE
No
Sponsors
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Reprogenetics, Livingston, NJ
UNKNOWN
Long Island IVF, Melville, NY
UNKNOWN
Reproductive Associates of Illinois, Highland Park, IL
UNKNOWN
Yale University
OTHER
McGill University
OTHER
BlueGnome, Cambridge, UK
UNKNOWN
Southern California Reproductive Center, CA
UNKNOWN
Reprogenetics
INDUSTRY
Responsible Party
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Principal Investigators
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Santiago Munne, PhD
Role: STUDY_DIRECTOR
Reprogenetics
Locations
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Southern California Reproductive Center
Beverly Hills, California, United States
Reproductive Associates of Illinois
Highland Park, Illinois, United States
Reprogenetics
Livingston, New Jersey, United States
Long Island IVF
Melville, New York, United States
Countries
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References
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Gutierrez-Mateo C, Colls P, Sanchez-Garcia J, Escudero T, Prates R, Ketterson K, Wells D, Munne S. Validation of microarray comparative genomic hybridization for comprehensive chromosome analysis of embryos. Fertil Steril. 2011 Mar 1;95(3):953-8. doi: 10.1016/j.fertnstert.2010.09.010. Epub 2010 Oct 25.
Cohen J, Wells D, Munne S. Removal of 2 cells from cleavage stage embryos is likely to reduce the efficacy of chromosomal tests that are used to enhance implantation rates. Fertil Steril. 2007 Mar;87(3):496-503. doi: 10.1016/j.fertnstert.2006.07.1516. Epub 2006 Dec 4.
Munne S, Wells D, Cohen J. Technology requirements for preimplantation genetic diagnosis to improve assisted reproduction outcomes. Fertil Steril. 2010 Jul;94(2):408-30. doi: 10.1016/j.fertnstert.2009.02.091. Epub 2009 May 5.
Schoolcraft WB, Fragouli E, Stevens J, Munne S, Katz-Jaffe MG, Wells D. Clinical application of comprehensive chromosomal screening at the blastocyst stage. Fertil Steril. 2010 Oct;94(5):1700-6. doi: 10.1016/j.fertnstert.2009.10.015. Epub 2009 Nov 25.
De Vos A, Staessen C, De Rycke M, Verpoest W, Haentjens P, Devroey P, Liebaers I, Van de Velde H. Impact of cleavage-stage embryo biopsy in view of PGD on human blastocyst implantation: a prospective cohort of single embryo transfers. Hum Reprod. 2009 Dec;24(12):2988-96. doi: 10.1093/humrep/dep251. Epub 2009 Sep 21.
Other Identifiers
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Reprogenetics study 389
Identifier Type: OTHER
Identifier Source: secondary_id
Reprogenetics study 389
Identifier Type: -
Identifier Source: org_study_id