Comparison of Standard ART Practice vs. Trophectoderm Biopsy and Whole Chromosome Analysis
Status unconfirmed · Phase 2
Conditions studied: Infertility, Recurrent Pregnancy Loss
In brief
We propose to perform a clinical randomized trial to evaluate the effect of blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS) in comparison to standard Assisted Reproductive Technologies (ART) methods on on implantation rates, miscarriage rates, and pregnancy rates. This will be three studies into one: a) a comparison of treatment (NGS) and no treatment, b) a non-selection study based on the control group for which we will replace without knowing the ploidy of the embryos, but we will know it later, c) a retrospective study about the use of Mitochondrial DNA as a selection tool.
Key facts
- Study ID
- NCT01946945
- Run by
- Reprogenetics
- People needed
- 240
- Starts
- 2013-09-01
- Last updated by the study team
- 2014-09-09
Who can join
Age: 18 and older, up to 42. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- All patients medically cleared to do a fresh or frozen embryo transfer.
- Age up to 42 years
You may not qualify if…
- microsurgical epididymal sperm aspiration (MESA) and Testicular sperm extraction (TESE) patients
- At least one partner carrier of a chromosomal or genetic disease
- Abnormal ovarian reserve, defined as follicle stimulating hormone (FSH) of >10 IU/L on day 2-4 of the cycle and anti-mullerian hormone (AMH) < 1ng /ml (If only one of the two parameters altered then patients is acceptable). This is based on Mandy Katz abstract at American Society for Reproductive Medicine (ASRM) 2011 where they showed that these patients have 35% chance of having no euploid embryos - They are excluded only to make the study size smaller, otherwise, if an euploid embryo is found in these patients, they implant as well as patients with normal ovarian reserve. Not all centers do AMH testing - we recommend first to run FSH and only test AMH if FSH is abnormal.
- Egg donor cycle (sperm donor is acceptable)
- Gender selection cycles
- Thaw cycles
Where it is running
- Reprogenetics — Livingston, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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