Comparison of Frozen-thawed Embryo Transfers and Fresh Embryo Transfers With Whole Chromosome Analysis Using Next Generation Sequencing
This trial is active, not recruiting.
|Collaborator||Reproductive Medicine Lab, LLC|
|Start date||September 2013|
|End date||December 2015|
|Trial size||186 participants|
|Trial identifier||NCT02000349, Reprogenetics-3.117|
The investigators propose to perform a clinical randomized trial to evaluate the effect of a frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS).
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
time frame: 8 weeks after replacement
Correlation of Mitochondrial DNA and implantation
time frame: When a fetal heartbeat is detected (8 weeks after implantation)
Female participants from 18 years up to 42 years old.
Inclusion Criteria (pre-stimulation): - Age up to 42 years Exclusion Criteria (pre-stimulation): - MESA and TESE patients - At least one partner carrier of a chromosomal abnormality - Egg donor cycle (sperm donor is acceptable) - Gender selection cycles - Thaw cycles - Any patient who cannot have a fresh embryo transfer - FSH above 12 or AMH less than 1
|Description||1. Fresh group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5, analyzed by NGS, and will have one or two euploid embryo transferred on day 6, in the am. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*). Any morulas developing to hatching blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle. 2. Frozen group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5 or day 6, embryos will then be vitrified, analyzed by NGS, and will have one or two euploid embryo(s) thawed and transferred on a FET cycle, before noon. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*). (*) Hatching blastocysts as described by Gardner and Schoolcraft (1999):|
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