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NCT02884063 Clinical Trial

Utilizing Free DNA in Embryo Culture for PGT

Genetic Diseases, Inborn Clinical Trial

Official title:
Utilizing Free DNA in Embryo Culture Media for Preimplantation Genetic Screening

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02884063
Other study ID # NGS-PGT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2015
Est. completion date December 1, 2019

Study information
Verified date August 2021
Source Al Baraka Fertility Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 1, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - all abnormal/aneuploidy embryos rejected for embryo transfer. Exclusion Criteria: - all embryos had unsuccessful diagnosis with blastomere biopsy.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• NGS reading for Media Free DNA
NGS reading for Media Free DNA instead of blstomer biopsy

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Al Baraka Fertility Hospital Ibn Sina Hospital, Sadat City University

Outcome
Type Measure Description Time frame Safety issue
Primary DNA isolation reading amplified DNA using NGS 2 years
Secondary NGS evaluation Free DNA isolation and amplification using WGA 2 years
Secondary Comparison with cell reading using NGS compare the obtained result with the results provided collected for the same embryo using its blastomer for PGS 2 years
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