NCT02313311

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

December 7, 2014

Last Update Submit

December 7, 2014

Conditions

Embryo

Keywords

Cleavage pattern, timing parameter, time-lapse

Outcome Measures

Primary Outcomes (1)

  • good-quality blastocyst rate

    6 days post insemination

Interventions

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.

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women undergoing assistant reproduction treatment

You may qualify if:

  • Women undergoing assistant reproduction treatment

You may not qualify if:

  • Oocyte donation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Time-Lapse Imaging

Intervention Hierarchy (Ancestors)

PhotographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Haixiang Sun, Dr.

    Reproductive Medicine Centre, Drum Affiliated to Hospital Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gulou Hospital

Study Record Dates

First Submitted

December 7, 2014

First Posted

December 10, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

December 10, 2014

Record last verified: 2014-12