Chromosome TranslocationNCT05216068
Investigation and Diagnosis of the Chromosome Variation in Donated/abandoned Blastocyst
A study testing NGS in people with Chromosome Translocation and Genetic Disorders in Pregnancy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Blastocysts derived from patients seeking infertility treatment were generated by in vitro fertilization and embryo culture as previously described, and were evaluated using the Gardner system. As part of the embryo selection process, cells of TE biopsy were collected, and blastocysts were vitrified. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Chromosome Translocation, Genetic Disorders in Pregnancy, Recurrent Miscarriage
- What is being tested?
- NGS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2021to 30 Nov 2024
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- the surplus blastocysts
- parents consent to donate the embryos
Who cannot join
- not agree to participate in this program
- whose embryo morphology and quality do not meet the technical requirements for genetic testing
Trial locations and contacts
1 site in 1 country.
About this study
Blastocysts derived from patients seeking infertility treatment were generated by in vitro fertilization and embryo culture as previously described, and were evaluated using the Gardner system. As part of the embryo selection process, cells of TE biopsy were collected, and blastocysts were vitrified. The clinical TE biopsies were subjected to whole genome amplification (WGA) with SurePlex reagents (Illumina) followed by NGS-based PGT-A using Illumina's VeriSeq kit (Illumina) on a MiSeq system (Illumina) according to the manufacturer's protocol.
Read the detailed description
Collected 200 donate abandonment embryos (well-developed blastocysts) for research under the National Assisted Reproduction Act of Taiwan.
- Collected 200 donate abandonment embryos: Five to six days after egg retrieval, well-developed embryos (called blastocysts).
- Blastocysts derived from patients seeking infertility treatment were generated.
- Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC embryo.
- To standardize the operating procedures
- Paper writing.
- Being tested
- NGS
- Keywords
- pre-implantation genetic diagnosis, balanced reciprocal translocation (BRT), structural variation (SV), next generation sequencing, abandoned blastocysts
- Medical subject headings
- Translocation, Genetic, Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGSDiagnostic test
Based on the next generation sequencing (NGS), WES can identify single nucleotide variants (SNVs) and small variants.
| Study group | Role | What they receive |
|---|---|---|
| donated abandonment embryos | Other | Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC. Receives: Diagnostic Test: NGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst aneuploidy rate
anormal Karyotype according to human genome 19 or updated version
Measured: 28 days
Secondary outcomes (1)
Whole genome amplification rate
success rate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Dec 2021
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chromosome TranslocationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216068
- Sponsor's protocol ID
- CMRPG8M0241
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2022
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation and Diagnosis of the Chromosome Variation in Donated/abandoned Blastocyst
- ClinicalTrials.gov ID
- NCT05216068
- Acronym / sponsor ID
- CMRPG8M0241
- Keywords
- pre-implantation genetic diagnosis, balanced reciprocal translocation (BRT), structural variation (SV), next generation sequencing, abandoned blastocysts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 31 Jan 2022 (actual)
- 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.
Blastocysts derived from patients seeking infertility treatment were generated by in vitro fertilization and embryo culture as previously described, and were evaluated using the Gardner system. As part of the embryo selection process, cells of TE biopsy were collected, and blastocysts were vitrified. The clinical TE biopsies were subjected to whole genome amplification (WGA) with SurePlex reagents (Illumina) followed by NGS-based PGT-A using Illumina's VeriSeq kit (Illumina) on a MiSeq system (Illumina) according to the manufacturer's protocol.
Detailed description
Collected 200 donate abandonment embryos (well-developed blastocysts) for research under the National Assisted Reproduction Act of Taiwan.
- Collected 200 donate abandonment embryos: Five to six days after egg retrieval, well-developed embryos (called blastocysts).
- Blastocysts derived from patients seeking infertility treatment were generated.
- Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC embryo.
- To standardize the operating procedures
- Paper writing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| donated abandonment embryos | Other | Diagnostic Test: NGSEmbryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- the surplus blastocysts
- parents consent to donate the embryos
Key exclusion criteria (2 listed)
- not agree to participate in this program
- whose embryo morphology and quality do not meet the technical requirements for genetic testing
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 |
|---|---|---|
| NGSBased on the next generation sequencing (NGS), WES can identify single nucleotide variants (SNVs) and small variants. | Diagnostic test | donated abandonment embryos |
Primary outcome
Blastocyst aneuploidy rate
Time frame: 28 days
anormal Karyotype according to human genome 19 or updated version
1 secondary outcome
Whole genome amplification rate
Time frame: 7 days
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 20 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NGS in people with Chromosome Translocation and Genetic Disorders in Pregnancy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Blastocyst aneuploidy rate (time frame: 28 days). 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 20 Feb 2025.