Utilizing Free DNA in Embryo Culture for PGT

August 13, 2021 updated by: Ahmad Mustafa Mohamed Metwalley, Al Baraka Fertility Hospital

Utilizing Free DNA in Embryo Culture Media for Preimplantation Genetic Screening

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Compare 100 embryos studied using NGS for chromosomal aneuploidies, and compare the results came from free media DNA with this results.

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Embryos arranged for PGS study

Description

Inclusion Criteria:

  • all abnormal/aneuploidy embryos rejected for embryo transfer.

Exclusion Criteria:

  • all embryos had unsuccessful diagnosis with blastomere biopsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Media Free DNA instead of blstomer biopsy
NGS reading for blastomer DNA
DNA extracted from Blastomere used for aneuploidy screening.
Procedure: NGS reading for Media Free DNA
NGS reading for Media Free DNA instead of blstomer biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DNA isolation
Time Frame: 2 years
reading amplified DNA using NGS
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NGS evaluation
Time Frame: 2 years
Free DNA isolation and amplification using WGA
2 years
Comparison with cell reading using NGS
Time Frame: 2 years
compare the obtained result with the results provided collected for the same embryo using its blastomer for PGS
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al Baraka Fertility Hospital

Collaborators

Ibn Sina Hospital
Sadat City University

Investigators

  • Study Director: Omima Khamis, PHD, Genetic Engineering Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NGS-PGT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

To publish it when it is completed.

IPD Sharing Time Frame

once final results released.

IPD Sharing Access Criteria

01-December 2019

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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