Embryoscope and Reproductive Outcome | NCT02764255

Studies
Embryoscope and Reproductive Outcome

NCT02764255

Sponsor

Ahmed Maged

Status

Completed

Last Update Posted

Jul 25, 2017Actual

Enrollment

770Actual

Phase

Not provided

Conditions

Invitro Fertilization

Interventions

Not provided

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

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

May 4, 2016

First Submission Date that Met QC Criteria

May 4, 2016

First Posted Date

May 6, 2016Estimated

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

Jul 24, 2017

Last Update Posted Date

Jul 25, 2017Actual

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

cases with embyos cultured in the standard incubator and evaluated only by morphology are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model

Detailed Description

cases with embyos cultured in the standard incubator and evaluated only by morphology (control group) are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model(study group)

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

770Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
embryoscope group		cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model
control group		cases with embyos cultured in the standard incubator and evaluated only by morphology

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate	transvaginal ultrasound done to assess the gestational sac	14 days after embryo transfer

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient age:25-40 years old
BMI:18-30
patients with first or second ICSI trial

Exclusion criteria:

AMH <1
severe male factor(total motile sperm <1 million)
frozen embryo transfer cycles
patients with endocrinopathies or thrombophilia
patients on medical treatment which may interfere with results
hydrosalpinx

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

770 women undergoing ICSI cycles

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Maged, MD	Kasr Alainy medical school	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided