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Utilizing Free DNA in Embryo Culture for PGS

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ClinicalTrials.gov Identifier: NCT02884063
Recruitment Status : Unknown
Verified August 2016 by Ahmad Mustafa Mohamed Metwalley, Al Baraka Fertility Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : August 30, 2016
Last Update Posted : August 31, 2016
Sponsor:
Collaborators:
Ibn Sina Hospital
Sadat City University
Information provided by (Responsible Party):
Ahmad Mustafa Mohamed Metwalley, Al Baraka Fertility Hospital

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.


Condition or disease Intervention/treatment
Chromosome Abnormalities Genetic Diseases, Inborn Mutation Procedure: NGS reading for Media Free DNA

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
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utilizing Free DNA in Embryo Culture Media for Preimplantation Genetic Screening
Study Start Date : May 2015
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. DNA isolation [ Time Frame: 2 years ]
    reading amplified DNA using NGS


Secondary Outcome Measures :
  1. NGS evaluation [ Time Frame: 2 years ]
    Free DNA isolation and amplification using WGA

  2. 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


Biospecimen Retention:   Samples With DNA
Blastomer for growing IVF embryos culture media with its free DNA


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Embryos arranged for PGS study
Criteria

Inclusion Criteria:

  • all abnormal/aneuploidy embryos rejected for embryo transfer.

Exclusion Criteria:

  • all embryos had unsuccessful diagnosis with blastomere biopsy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884063


Sponsors and Collaborators
Al Baraka Fertility Hospital
Ibn Sina Hospital
Sadat City University
Investigators
Study Director: Omima Khamis, PHD Genetic Engineering Institute

Additional Information:
Responsible Party: Ahmad Mustafa Mohamed Metwalley, IVF laboratory manager, Al Baraka Fertility Hospital
ClinicalTrials.gov Identifier: NCT02884063     History of Changes
Other Study ID Numbers: NGS-PGS
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To publish it when it is completed

Keywords provided by Ahmad Mustafa Mohamed Metwalley, Al Baraka Fertility Hospital:
PGS
PGD
free embryo DNA
NGS

Additional relevant MeSH terms:
Genetic Diseases, Inborn
Chromosome Aberrations
Chromosome Disorders
Pathologic Processes
Congenital Abnormalities