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The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis (PGD) increases implantation and delivery rates in couples attempting to conceive through in vitro fertilization (IVF).
FISH based PGD techniques have provided little improvement in implantation and delivery rates. We believe that the use of 24 chromosome PGD, as compared to control (no PGD) will show a benefit to patients. This study is a randomized clinical trial that seeks to validate 24 chromosome PGD.
Patients that meet the eligibility criteria will be randomized prior to embryo transfer. In order to be randomized, the patient must have blastulated embryos suitable for biopsy on day 5. Half of the patients will received 24 chromosome PGD and will have 2 PGD normal embryos transferred. Half the the patients will receive no PGD and the 2 morphologically best embryos will be transferred. Follow up on pregnant patients will be a blood draw at approximately 9 weeks gestation and buccal swabs collected from the infant(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (no PGD) | Receive their planned IVF treatment without PGD. 2 morphologically best embryos are transferred. | ||
| Case (PGD) | Receive PGD in addition to their planned IVF Cycle. 2 morphologically best PGD normal embryos are transferred. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sustained Implantation Rate Per Embryo Transferred | Implantation rate per embryo transferred | Within 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle | Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle | Within 1 Year |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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500 patients attempting conception through IVF who have a maximum of one prior failed IVF cycle.
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| Name | Affiliation | Role |
|---|---|---|
| Richard T Scott, MD | Reproductive Medicine Associates of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Center for Reproductive Medicine | Lone Tree | Colorado | 18104 | United States | ||
| Reproductive Medicine Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23731996 | Derived | Scott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1. |
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Blood samples from the male and female partners. Buccal swabs from infants.
| Morristown |
| New Jersey |
| 07960 |
| United States |
| Reproductive Medicine Associates of PA at Lehigh Valley | Allentown | Pennsylvania | 18104 | United States |