Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01546350
Status:
SUSPENDED
Last Update Posted:
2013-08-21
First Post:
2012-03-02
Brief Title:
Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH
Sponsor:
Reprogenetics
Organization:
Reprogenetics
Study Overview
Official Title:
Comparison of Standard ART Practice vs Trophectoderm Biopsy Array CGH Analysis and Day-6 Replacement of a Single Euploid Embryo
Status:
SUSPENDED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not enough patients recruited on time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 AB 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 AB or C blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle
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 AB 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 AB or C blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle
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
The study may be extended to evaluate secondary efficacy endpoints which will be miscarriage rate and take home baby rates comparing the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Reprogenetics study 389 | OTHER | Reprogenetics | None |