Utilizing Free DNA in Embryo Culture for PGT

Sponsor
Al Baraka Fertility Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02884063
Collaborator
Ibn Sina Hospital (Other), Sadat City University (Other)
100
55

Study Details

Study Description

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 Phase
  • 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 Design

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 1, 2015
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. DNA isolation [2 years]

    reading amplified DNA using NGS

Secondary Outcome Measures

  1. NGS evaluation [2 years]

    Free DNA isolation and amplification using WGA

  2. Comparison with cell reading using NGS [2 years]

    compare the obtained result with the results provided collected for the same embryo using its blastomer for PGS

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • all abnormal/aneuploidy embryos rejected for embryo transfer.
Exclusion Criteria:
  • all embryos had unsuccessful diagnosis with blastomere biopsy.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Al Baraka Fertility Hospital
  • Ibn Sina Hospital
  • Sadat City University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Ahmad Mustafa Mohamed Metwalley, IVF laboratory manager, Al Baraka Fertility Hospital
ClinicalTrials.gov Identifier:
NCT02884063
Other Study ID Numbers:
  • NGS-PGT
First Posted:
Aug 30, 2016
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Ahmad Mustafa Mohamed Metwalley, IVF laboratory manager, Al Baraka Fertility Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2021