NCT02673125

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

February 1, 2016

Last Update Submit

March 14, 2016

Conditions

Infertility

Keywords

Preimplantation Genetic Screening

Outcome Measures

Primary Outcomes (1)

  • Implantation rates between MitoGrade normal and MitoGrade elevated embryos

    Using DNA fingerprinting (via cheek swab) to determine which embryo implanted

    Post natal analysis (9-10 months after replacement)

Study Arms (1)

Double embryo transfer

EXPERIMENTAL

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

Genetic: MitoGrade

Interventions

MitoGradeGENETIC

MitoGrade refers to the mitochondrial DNA assessment in embryos.

Double embryo transfer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reprogenetics

Livingston, New Jersey, 07039, United States

RECRUITING

Related Publications (1)

  • Fragouli E, Spath K, Alfarawati S, Kaper F, Craig A, Michel CE, Kokocinski F, Cohen J, Munne S, Wells D. Altered levels of mitochondrial DNA are associated with female age, aneuploidy, and provide an independent measure of embryonic implantation potential. PLoS Genet. 2015 Jun 3;11(6):e1005241. doi: 10.1371/journal.pgen.1005241. eCollection 2015 Jun.

    PMID: 26039092RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Santiago Munne, PhD

    Reprogenetics

    STUDY DIRECTOR

Central Study Contacts

Krithika Ravichandran, MSc

CONTACT

973-436-5000research@reprogenetics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 3, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations

US(1)