Prospective Paired Study on the Effectiveness of MitoGrade
Status unconfirmed · Not applicable
Conditions studied: Infertility
In brief
Chromosomal abnormalities are a major cause of pregnancy loss. Preimplantation Genetic Screening (PGS) using Next Generation Sequencing (NGS) allows the effective detection of these abnormalities and improves clinical outcomes. However even the transfer of a chromosomally normal embryo does not guarantee successful implantation. Recent research by Fragouli, et. al. 2015 has demonstrated a strong association between mitochondrial DNA quantities (also known as MitoGradeTM) and implantation outcomes in embryos that are already classified by PGS as chromosomally normal. Investigators have also demonstrated in a clinical study that MitoGradeTM normal and PGS normal embryos have higher chances of implantation than MitoGrade elevated PGS normal embryos. Transferring MitoGrade elevated PGS normal embryos results in less than 10% implantation rates while MitoGrade normal PGS normal embryos resulted in more than 65% implantation rates. The risk of miscarriage after replacing either type is very low (about 8%). In order to understand the complete effectiveness of the test, investigators are conducting a paired prospective study. This means that investigators will be transferring a MitoGrade normal and a MitoGrade elevated embryo at the same time to see if one implants better than the other. It is expected that patients joining this study will benefit from knowing that at least one embryo is MitoGrade normal PGS normal.
Key facts
- Study ID
- NCT02673125
- Run by
- Reprogenetics
- People needed
- 60
- Starts
- 2015-12-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2016-03-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Center criteria:
- Offered only to those clinics with >20% MitoGrade elevated embryos
- Patient criteria:
- Persons undergoing IVF and Preimplantation genetic screening (PGS) through Next Generation Sequencing (NGS) will be eligible to be a part of the study.
- The study will be limited to those patients who have 4 or more PGS-classified normal embryos
- Patients not undergoing PGS will not be included as part of the study.
- Patients undergoing PGD (for genetic disorders) plus PGS will be excluded.
You may not qualify if…
- No other specific group of individuals (age, ethnicity, egg donation, etc) will be excluded.
Where it is running
- Reprogenetics — Livingston, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.