EmbryoSETLSSETNCT02313311
Select Embryos by Time-lapse System for Single Embryo Transfer
An observational study of Embryo, run by Li-jun Ding.
Trial summary
The objective of this study is to establish a hierarchical embryo selection process by using the time-lapse imaging (TLI), combining the embryo cleavage patterns and timing parameters. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo
- What is being tested?
- time-lapse imaging
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women undergoing assistant reproduction treatment
Who may be able to join
- Women undergoing assistant reproduction treatment
Who cannot join
- Oocyte donation cycles
About this study
Official title: Study Embryos of IVF by Time-lapse System
The objective of this study is to establish a hierarchical embryo selection process by using the time-lapse imaging (TLI), combining the embryo cleavage patterns and timing parameters.
Read the detailed description
The embryos of patients undergoing in vitro fertilization (IVF) treatment is cultured to blastocyst stage and observed by TLI. The association of embryo cleavage patterns/timing parameters and good-quality blastocyst rates are evaluated by logistic regression and to establish a hierarchical embryo selection. The value of the selection process is assess by single embryo transfer (SET) on Day 3.
- Conditions
- Embryo
- Being tested
- time-lapse imaging
- Keywords
- Cleavage pattern, timing parameter, time-lapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time-lapse imagingOther
Embryos are observed using time-lapse imaging (Primo Vision®). It is an incubator with a compact, sealed, and digitally inverted camera unit which can automatically acquire images.The system can record the actual developmental stage of the embryos, all the recorded images can be saved to be analyzed later using a special software program.
What is being measured
The primary outcome is the main question the study is designed to answer.
good-quality blastocyst rate
Measured: 6 days post insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmbryoStudies 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
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li-jun Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li-jun Ding, Nanjing University
- Investigators
- Haixiang Sun, Dr., Principal investigator, Reproductive Medicine Centre, Drum Affiliated to Hospital Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313311
- Sponsor's protocol ID
- LJ201102-BK20141087-BL2014003
- Other IDs
- LJ201102
- Acronym
- SETLSSET
- Status last verified
- Dec 2014
- First submitted
- 7 Dec 2014
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Embryos of IVF by Time-lapse System
- ClinicalTrials.gov ID
- NCT02313311
- Acronym / sponsor ID
- SETLSSET / LJ201102-BK20141087-BL2014003
- Conditions
- Embryo
- Keywords
- Cleavage pattern, timing parameter, time-lapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Li-jun DingUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Dec 2014 (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.
The objective of this study is to establish a hierarchical embryo selection process by using the time-lapse imaging (TLI), combining the embryo cleavage patterns and timing parameters.
Detailed description
The embryos of patients undergoing in vitro fertilization (IVF) treatment is cultured to blastocyst stage and observed by TLI. The association of embryo cleavage patterns/timing parameters and good-quality blastocyst rates are evaluated by logistic regression and to establish a hierarchical embryo selection. The value of the selection process is assess by single embryo transfer (SET) on Day 3.
Study design
- Observational model
- Cohort
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women undergoing assistant reproduction treatment
Key inclusion criteria (1 listed)
- Women undergoing assistant reproduction treatment
Key exclusion criteria (1 listed)
- Oocyte donation cycles
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 |
|---|---|---|
| time-lapse imagingEmbryos are observed using time-lapse imaging (Primo Vision®). It is an incubator with a compact, sealed, and digitally inverted camera unit which can automatically acquire images.The system can record the actual developmental stage of the embryos, all the recorded images can be saved to be analyzed later using a special software program. | Other | – |
Primary outcome
good-quality blastocyst rate
Time frame: 6 days post insemination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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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.
Haixiang Sun, Dr. principal investigator
Reproductive Medicine Centre, Drum Affiliated to Hospital Nanjing University Medical School
Questions about this trial
What is this clinical trial studying?
An observational study of Embryo, run by Li-jun Ding.
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: status not confirmed, as of the sponsor's last update on 10 Dec 2014. 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?
Results are not available in the source record.
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?
good-quality blastocyst rate (time frame: 6 days post insemination). 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 10 Dec 2014; AzTrials last refreshed its copy on 29 Oct 2026.