Comparison of Standard ART Practice vs. Trophectoderm Biopsy, Array CGH Analysis, and Day-6 Replacement of a Single Euploid Embryo
| City: |
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Highland Park |
| State: |
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Illinois |
| Zip Code: |
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60035 |
| Conditions: |
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Infertility - Recurrent Pregnancy Loss |
| Purpose: |
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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:
- 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.
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| Study Summary: |
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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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| Criteria: |
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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.
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| NCT ID: |
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NCT01546350 |
| Primary Contact: |
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Study Director
Santiago Munne, PhD
Reprogenetics
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| Backup Contact: |
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N/A |
| Location Contact: |
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Highland Park, Illinois 60035
United States
Ilynne McGovern
Phone: 847-266-3535
Email: Ilynne.mcgovern@integramed.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
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