Chromosome AbnormalitiesNCT02884063
Utilizing Free DNA in Embryo Culture for PGT
An observational study of Chromosome Abnormalities and Genetic Diseases, Inborn, run by Al Baraka Fertility Hospital.
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… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Chromosome Abnormalities, Genetic Diseases, Inborn, Mutation
- What is being tested?
- NGS reading for Media Free DNA
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2015to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Embryos arranged for PGS study
Who may be able to join
- all abnormal/aneuploidy embryos rejected for embryo transfer.
Who cannot join
- all embryos had unsuccessful diagnosis with blastomere biopsy.
About this study
Official title: Utilizing Free DNA in Embryo Culture Media for Preimplantation Genetic Screening
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.
- Conditions
- Chromosome Abnormalities, Genetic Diseases, Inborn, Mutation
- Being tested
- NGS reading for Media Free DNA
- Keywords
- PGS, PGD, free embryo DNA, NGS, PGT, PGT-a, PGT-m, PGT-HLA
- Medical subject headings
- Chromosome Aberrations, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS reading for Media Free DNAProcedure or surgery
NGS reading for Media Free DNA instead of blstomer biopsy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: NGS reading for Media Free DNA | |
| NGS reading for blastomer DNA | DNA extracted from Blastomere used for aneuploidy screening. Receives: Procedure: NGS reading for Media Free DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA isolation
reading amplified DNA using NGS
Measured: 2 years
Secondary outcomes (2)
NGS evaluation
Free DNA isolation and amplification using WGA
Measured: 2 years
Comparison with cell reading using NGS
compare the obtained result with the results provided collected for the same embryo using its blastomer for PGS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMay 2015
- Primary completion1 Dec 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromosome AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al Baraka Fertility Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ibn Sina Hospital, Sadat City University
- Responsible party
- Principal investigator, Ahmad Mustafa Mohamed Metwalley, Al Baraka Fertility Hospital
- Investigators
- Omima Khamis, PHD, Study director, Genetic Engineering Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884063
- Sponsor's protocol ID
- NGS-PGT
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2016
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: To publish it when it is completed.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Free DNA in Embryo Culture Media for Preimplantation Genetic Screening
- ClinicalTrials.gov ID
- NCT02884063
- Acronym / sponsor ID
- NGS-PGT
- Conditions
- Chromosome Abnormalities, Genetic Diseases, Inborn, Mutation
- Keywords
- PGS, PGD, free embryo DNA, NGS, PGT, PGT-a, PGT-m, PGT-HLA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al Baraka Fertility HospitalUniversity, hospital or other
- Collaborators
- Ibn Sina Hospital, Sadat City University
- Study start
- May 2015
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NGS reading for Media Free DNA | – | Procedure: NGS reading for Media Free DNAAbility to read the DNA product available in embryo culture media using NGS to have valuable diagnostic image for genetic composition of embryo before implantation. |
| NGS reading for blastomer DNA | – | Procedure: NGS reading for Media Free DNADNA extracted from Blastomere used for aneuploidy screening. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Embryos arranged for PGS study
Key inclusion criteria (1 listed)
- all abnormal/aneuploidy embryos rejected for embryo transfer.
Key exclusion criteria (1 listed)
- all embryos had unsuccessful diagnosis with blastomere biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGS reading for Media Free DNANGS reading for Media Free DNA instead of blstomer biopsy | Procedure or surgery | NGS reading for Media Free DNA, NGS reading for blastomer DNA |
Primary outcome
DNA isolation
Time frame: 2 years
reading amplified DNA using NGS
2 secondary outcomes
NGS evaluation
Time frame: 2 years
Comparison with cell reading using NGS
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: Yes. To publish it when it is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omima Khamis, PHD study director
Genetic Engineering Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Chromosome Abnormalities and Genetic Diseases, Inborn, run by Al Baraka Fertility Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA isolation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.