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| ID | Type | Description | Link |
|---|---|---|---|
| Reprogenetics study 389 | Other Identifier | Reprogenetics |
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not enough patients recruited on time
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| Name | Class |
|---|---|
| Reprogenetics, Livingston, NJ | UNKNOWN |
| Long Island IVF, Melville, NY | UNKNOWN |
| Reproductive Associates of Illinois, Highland Park, IL | UNKNOWN |
| Yale University |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - regular ART treatment | No Intervention | 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 - PGD | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PGD | Genetic | array CGH after blastocyst biopsy |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Implantation rate | fetal sacs / embryos replaced | First month after replacement |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous miscarriage rate | pregnancies lost / pregnancies of cycles randomized | during first and second trimester of pregnancy |
| ongoing pregnancy rate | pregnancies past second trimester / cycles started |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria during stimulation:
Exclusion criteria on day 5 post retrieval:
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Munne, PhD | Reprogenetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Reproductive Center | Beverly Hills | California | 92677 | United States | ||
| Reproductive Associates of Illinois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20971462 | Background | 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. | |
| 17141767 | Background |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
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| ID | Term |
|---|---|
| D011457 | Prostaglandins D |
| ID | Term |
|---|---|
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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| OTHER |
| McGill University | OTHER |
| BlueGnome, Cambridge, UK | UNKNOWN |
| Southern California Reproductive Center, CA | UNKNOWN |
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| PGD | Procedure | PGD using blastocyst biopsy and testing of the biopsy by array CGH |
|
| third trimester of pregnancy |
| Multiple pregnancy rate | Twin or multiple order pregnancies / total pregnancies | first month after transfer |
| Highland Park |
| Illinois |
| 60035 |
| United States |
| Reprogenetics | Livingston | New Jersey | 07039 | United States |
| Long Island IVF | Melville | New York | 11747 | United States |
| 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. |
| 19409550 | Background | 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. |
| 19939370 | Background | 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. |
| 19773223 | Background | 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. |
| D008055 |
| Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |