NCT02884063

Brief Summary

In the way for developing and optimizing protocol to be used as non- invasive methodology used as routine testing for PGS. This protocol is to be adapted to replace the using of life embryo cells for genetic testing and aneuploidy study as well as for any type of genetic testing including single gene disorder or HLA typing or study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Status
completed

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

May 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

3.6 years

First QC Date

August 22, 2016

Last Update Submit

August 13, 2021

Conditions

Chromosome AbnormalitiesGenetic Diseases, InbornMutation

Keywords

PGSPGDfree embryo DNANGSPGTPGT-aPGT-mPGT-HLA

Outcome Measures

Primary Outcomes (1)

  • DNA isolation

    reading amplified DNA using NGS

    2 years

Secondary Outcomes (2)

  • NGS evaluation

    2 years

  • Comparison with cell reading using NGS

    2 years

Study Arms (2)

NGS reading for Media Free DNA

Ability to read the DNA product available in embryo culture media using NGS to have valuable diagnostic image for genetic composition of embryo before implantation.

Procedure: NGS reading for Media Free DNA

NGS reading for blastomer DNA

DNA extracted from Blastomere used for aneuploidy screening.

Procedure: NGS reading for Media Free DNA

Interventions

NGS reading for Media Free DNAPROCEDURE

NGS reading for Media Free DNA instead of blstomer biopsy

NGS reading for Media Free DNANGS reading for blastomer DNA

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Embryos arranged for PGS study

You may qualify if:

  • all abnormal/aneuploidy embryos rejected for embryo transfer.

You may not qualify if:

  • all embryos had unsuccessful diagnosis with blastomere biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blastomer for growing IVF embryos culture media with its free DNA

MeSH Terms

Conditions

Chromosome AberrationsGenetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Omima Khamis, PHD

    Genetic Engineering Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF laboratory manager

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 30, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

To publish it when it is completed.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
once final results released.
Access Criteria
01-December 2019