Select Embryos by Time-lapse System for Single Embryo Tra... | NCT02313311

Studies
Select Embryos by Time-lapse System for Single Embryo Transfer

NCT02313311

Sponsor

Li-jun Ding

Status

Unknown status

Last Update Posted

Dec 10, 2014Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Embryo

Interventions

time-lapse imaging

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
LJ201102	Other Grant/Funding Number	Jiangsu Province, China

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2015Estimated

First Submitted Date

Dec 7, 2014

First Submission Date that Met QC Criteria

Dec 7, 2014

First Posted Date

Dec 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2014

Last Update Posted Date

Dec 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
time-lapse imaging	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
good-quality blastocyst rate		6 days post insemination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women undergoing assistant reproduction treatment

Exclusion Criteria:

Oocyte donation cycles

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women undergoing assistant reproduction treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haixiang Sun, Dr.	Reproductive Medicine Centre, Drum Affiliated to Hospital Nanjing University Medical School	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059008	Time-Lapse Imaging

Ancestor Terms

ID	Term
D010781	Photography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided