Time - Lapse Analysis of Frozen Embryos | NCT04255641

Studies
Time - Lapse Analysis of Frozen Embryos

NCT04255641

Sponsor

Carmel Medical Center

Status

Unknown status

Last Update Posted

Feb 5, 2020Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Frozen Embryos

Interventions

time lapse analysis

Countries

Israel

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

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2020Estimated

Primary Completion Date

Jun 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Feb 3, 2020

First Submission Date that Met QC Criteria

Feb 4, 2020

First Posted Date

Feb 5, 2020Actual

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

Feb 4, 2020

Last Update Posted Date

Feb 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

A retrospective analysis of embryo defrost cycles that were rated in the EmbryoScope system and frozen will be performed. The study will examine the possible association between the morphokinetic grading received by these embryos as fresh embryos before freezing, and their survival, the morphological grading they received after thawing, their proper rooting and live birth after thawing.

Detailed Description

Not provided

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
frozen embryos			Other: time lapse analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
time lapse analysis	Other	grading of the embryos before freezing using time lapse/	frozen embryos

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
live birth		1 day
embryos survival after thawing		1-2 days
implantation in the uterus		1 week
post thaw grading	post thaw grading of the embryos using time lapse analysis	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All women who underwent embryo freezing and thawing between the years 2014-2019 in Carmel medical center

Exclusion Criteria:

Lack of proper data

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

All women who underwent embryo freezing and thawing between the years 2014-2019 in Carmel medical center

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
zofnat wiener, dr	Contact	0544824046		wiener_zofnat@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center	Recruiting	Haifa		3436212	Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided