Genetic DisorderNCT03065114
Retrospective Study on Clinical Results of Preimplantation Genetic Screening at Different Embryo Stage
An observational study of Genetic Disorder and Fertility Disorders, run by Yeh.
Trial summary
Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality before transfer. Under this tool, patients with a family history of genetic disease or special genetic disease could avoid to produce chromosomal abnormalities of the next pregnant. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genetic Disorder, Fertility Disorders, Reproductive Disorder
- What is being tested?
- PGS
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 30 Nov 2015
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women underwent in vitro fertilization (IVF) treatment and preimplantational genetic screen (PGS).
Who may be able to join
- Women underwent in vitro fertilization (IVF) treatment and preimplantational genetic screen (PGS).
Who cannot join
- N/A
About this study
Official title: Institute of Medicine, Chung Shan Medical University
Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality before transfer. Under this tool, patients with a family history of genetic disease or special genetic disease could avoid to produce chromosomal abnormalities of the next pregnant. This study is a retrospective study, data collection from 2001 Jan. to 2015. Nov. Patients underwent PGS and data including the couples age, infertility factors, stimulation protocols, medicine records, embryo quality records and blood tests were collected in this study. Analysis the relationship between outcomes of PGS, clinical outcomes and embryo quality is performed and further to find a diagnosis reference for clinical care.
Read the detailed description
Research background Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality before transfer. Under this tool, patients with a family history of genetic disease or special genetic disease could avoid to produce chromosomal abnormalities of the next pregnant. For the preemergence of embryos before the genetic diagnosis must be carried out artificial reproductive treatment, the process includes induction of ovulation, ovulation, in vitro fertilization and embryo culture, to embryos grow to six to eight cells or cultured into the stage of blastocyst stage, Under the embryonic section, take one or several cells, the slices of cells for genetic diagnosis, select the embryo without genetic disease implanted in the uterine cavity, in order to avoid the birth of genetic disease offspring.
PGS can reduce the pregnancy when the chromosomal abnormalities of the fetus after implantation, but also to reduce the risk of abortion from chromosomal abnormalities, and can avoid the couples implanted with genetic abnormalities of the embryos, thereby significantly reducing it is important to promote the process of eugenics and reduce the social cost.
Research purposes The detection of chromosomal abnormalities of embryos are important factors for clinical diagnosis or screening before implantation. However, there is no complete analysis of domestic studies. This program will compare the genes or chromosomal abnormalities and clinical outcomes of embryo testing at different stages of embryonic development.
Research design This study is a retrospective study, data collection from 2001 Jan. to 2015. Nov. Patients underwent PGS and data including the couples age, infertility factors, stimulation protocols, medicine records, embryo quality records and blood tests were collected in this study. Analysis the relationship between outcomes of PGS, clinical outcomes and embryo quality is performed and further to find a diagnosis reference for clinical care.
- Conditions
- Genetic Disorder, Fertility Disorders, Reproductive Disorder
- Being tested
- PGS
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGSOther
chromosome abnormality test from PGS and relationship between embryo development
| Study group | Role | What they receive |
|---|---|---|
| PGSno. | blastocysts from patients underwent preimplantational genetic screen (PGS) prtocols. only euploid embryos were selected to transfer. Receives: Other: PGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate
detection sac after embryo transfer
Measured: 1~2 week after pregnancy test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start1 Dec 2014
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genetic DisorderStudies 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
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yeh, Chung Shan Medical University
- Investigators
- Maw-Sheng Lee, Phd, Study chair, Lee's Women Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065114
- Sponsor's protocol ID
- CS14124
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 27 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen HH, Huang CC, Cheng EH, Lee TH, Chien LF, Lee MS. Optimal timing of blastocyst vitrification after trophectoderm biopsy for preimplantation genetic screening. PLoS One. 2017 Oct 5;12(10):e0185747. doi: 10.1371/journal.pone.0185747. eCollection 2017.
PubMed 28982142
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institute of Medicine, Chung Shan Medical University
- ClinicalTrials.gov ID
- NCT03065114
- Acronym / sponsor ID
- CS14124
- Conditions
- Genetic Disorder, Fertility Disorders, Reproductive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- YehUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 27 Feb 2017 (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.
Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality before transfer. Under this tool, patients with a family history of genetic disease or special genetic disease could avoid to produce chromosomal abnormalities of the next pregnant. This study is a retrospective study, data collection from 2001 Jan. to 2015. Nov. Patients underwent PGS and data including the couples age, infertility factors, stimulation protocols, medicine records, embryo quality records and blood tests were collected in this study. Analysis the relationship between outcomes of PGS, clinical outcomes and embryo quality is performed and further to find a diagnosis reference for clinical care.
Detailed description
Research background Preimplantational genetic screen (PGS) is tool for diagnosis of embryo chromosome abnormality before transfer. Under this tool, patients with a family history of genetic disease or special genetic disease could avoid to produce chromosomal abnormalities of the next pregnant. For the preemergence of embryos before the genetic diagnosis must be carried out artificial reproductive treatment, the process includes induction of ovulation, ovulation, in vitro fertilization and embryo culture, to embryos grow to six to eight cells or cultured into the stage of blastocyst stage, Under the embryonic section, take one or several cells, the slices of cells for genetic diagnosis, select the embryo without genetic disease implanted in the uterine cavity, in order to avoid the birth of genetic disease offspring.
PGS can reduce the pregnancy when the chromosomal abnormalities of the fetus after implantation, but also to reduce the risk of abortion from chromosomal abnormalities, and can avoid the couples implanted with genetic abnormalities of the embryos, thereby significantly reducing it is important to promote the process of eugenics and reduce the social cost.
Research purposes The detection of chromosomal abnormalities of embryos are important factors for clinical diagnosis or screening before implantation. However, there is no complete analysis of domestic studies. This program will compare the genes or chromosomal abnormalities and clinical outcomes of embryo testing at different stages of embryonic development.
Research design This study is a retrospective study, data collection from 2001 Jan. to 2015. Nov. Patients underwent PGS and data including the couples age, infertility factors, stimulation protocols, medicine records, embryo quality records and blood tests were collected in this study. Analysis the relationship between outcomes of PGS, clinical outcomes and embryo quality is performed and further to find a diagnosis reference for clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PGSno. | – | Other: PGSblastocysts from patients underwent preimplantational genetic screen (PGS) prtocols. only euploid embryos were selected to transfer. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women underwent in vitro fertilization (IVF) treatment and preimplantational genetic screen (PGS).
Key inclusion criteria (1 listed)
- Women underwent in vitro fertilization (IVF) treatment and preimplantational genetic screen (PGS).
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| PGSchromosome abnormality test from PGS and relationship between embryo development | Other | PGSno. |
Primary outcome
implantation rate
Time frame: 1~2 week after pregnancy test
detection sac after embryo transfer
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 27 Feb 2017.
- Derived from this study: PubMed 28982142Chen HH, Huang CC, Cheng EH, Lee TH, Chien LF, Lee MS. Optimal timing of blastocyst vitrification after trophectoderm biopsy for preimplantation genetic screening. PLoS One. 2017 Oct 5;12(10):e0185747. doi: 10.1371/journal.pone.0185747. eCollection 2017.
- Individual participant dataSharing planned: Undecided
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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.
Maw-Sheng Lee, Phd study chair
Lee's Women Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Disorder and Fertility Disorders, run by Yeh.
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 27 Feb 2017. 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?
implantation rate (time frame: 1~2 week after pregnancy test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03065114, which also lists 1 linked publication.
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 27 Feb 2017.