Utilizing Free DNA in Embryo Culture for PGT

Completed

• Conditions: Genetic Diseases, Inborn; Mutation; Chromosome Abnormalities

• Registration Number: NCT02884063
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-30
• Primary Completion: 2018-12-01
• Study Completion: 2019-12-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• all abnormal/aneuploidy embryos rejected for embryo transfer.

Exclusion Criteria

• all embryos had unsuccessful diagnosis with blastomere biopsy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DNA isolation	2 years	reading amplified DNA using NGS

Secondary Outcome Measures

Name	Time	Method
NGS evaluation	2 years	Free DNA isolation and amplification using WGA
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