ClinicalTrials.gg
CompletedNCT02884063Updated Aug 19, 2021

Utilizing Free DNA in Embryo Culture for PGT

An observational study in Chromosome Abnormalities, Genetic Diseases, Inborn and Mutation, sponsored by Al Baraka Fertility Hospital. Completed. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-08-19.

Sponsored by Al Baraka Fertility Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Chromosome Abnormalities
  • Genetic Diseases, Inborn
  • Mutation

Keywords

  • PGS
  • PGD
  • free embryo DNA
  • NGS
  • PGT
  • PGT-a
  • PGT-m
  • PGT-HLA
03

In context

Chromosome Aberrations

48 studies on the registry are indexed under Chromosome Aberrations; 10 are open to participants now.

This study's enrollment of 100 is below the median of 231 across 30 observational studies indexed under Chromosome Aberrations.

Browse Chromosome Aberrations studies →

Lead sponsor

Al Baraka Fertility Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Embryos arranged for PGS study

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all abnormal/aneuploidy embryos rejected for embryo transfer.

Exclusion criteria

Exclusion Criteria:

  • all embryos had unsuccessful diagnosis with blastomere .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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 blastomer DNA

    DNA extracted from Blastomere used for aneuploidy screening.

    Procedure: NGS reading for Media Free DNA

Interventions

  • ProcedureNGS reading for Media Free DNA

    NGS reading for Media Free DNA instead of blstomer biopsy

06

What researchers measure

Primary outcomes

  1. DNA isolation

    reading amplified DNA using NGS

    Time frame: 2 years

Secondary outcomes

  1. NGS evaluation

    Free DNA isolation and amplification using WGA

    Time frame: 2 years

  2. Comparison with cell reading using NGS

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

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — To publish it when it is completed.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: once final results released.

Access criteria: 01-December 2019

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02884063
Lead sponsor
Al Baraka Fertility Hospital
Collaborators
Ibn Sina Hospital, Sadat City University
Responsible party
Ahmad Mustafa Mohamed Metwalley (IVF laboratory manager, Al Baraka Fertility Hospital) — Principal investigator
First posted
Aug 30, 2016
Start date
May 2015
Primary completion
Dec 1, 2018
Completion
Dec 1, 2019
Last update
Aug 19, 2021

Study contacts

Omima Khamis, PHD
study director · Genetic Engineering Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion