Recruiting

MitoGrade

Sponsor:

Reprogenetics

Code:

NCT02673125

Conditions

Infertility

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

MitoGrade

Study Details

Brief summary:

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.

Conditions

Infertility

Study ID

NCT02673125

Start date

Dec, 2015

Status verified date

Mar, 2016

Completion date

Jan, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Center criteria:

1. Offered only to those clinics with >20% MitoGrade elevated embryos

Patient criteria:

1. Persons undergoing IVF and Preimplantation genetic screening (PGS) through Next Generation Sequencing (NGS) will be eligible to be a part of the study.
2. The study will be limited to those patients who have 4 or more PGS-classified normal embryos
3. Patients not undergoing PGS will not be included as part of the study.
4. Patients undergoing PGD (for genetic disorders) plus PGS will be excluded.

Exclusion Criteria:

1. No other specific group of individuals (age, ethnicity, egg donation, etc) will be excluded.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Double embryo transfer

Patients with both MitoGrade normal and Mitograde elevated PGS normal embryos will have two embryos replaced- one Mitograde normal and one Mitograde elevated.

Interventions

MitoGrade

MitoGrade refers to the mitochondrial DNA assessment in embryos.

Primary outcome measure

  • Implantation rates between MitoGrade normal and MitoGrade elevated embryos [ Time Frame: Post natal analysis (9-10 months after replacement) ]

Central Contacts and Locations

Central contacts

Krithika Ravichandran, MSc

973-436-5000research@reprogenetics.com

Locations

Reprogenetics

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

973-436-5000research@reprogenetics.com

Principal Investigator:

Santiago Munne, Ph.D

More Information

Sponsor

Reprogenetics

Last update posted

Mar 15, 2016

Last verified

Mar, 2016

Keywords

  • Preimplantation Genetic Screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Reprogenetics on 2016-03-15.