Predicting Normal vs. Carrier Status in Euploid Embryos o... | NCT02178865

Studies
Predicting Normal vs. Carrier Status in Euploid Embryos of Translocation Carriers

NCT02178865

Sponsor

Reproductive Medicine Associates of New Jersey

Status

Completed

Last Update Posted

Mar 17, 2017Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Balanced Chromosomal Translocation

Interventions

Not provided

Countries

United States

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

Mar 2017

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

Jun 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Feb 2017Actual

First Submitted Date

Jun 26, 2014

First Submission Date that Met QC Criteria

Jun 27, 2014

First Posted Date

Jul 1, 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

Mar 16, 2017

Last Update Posted Date

Mar 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to assess the accuracy of predicting the normal or carrier status of human embryos resulting from in vitro-fertilization (IVF) from patients carrying a balanced translocation.

Detailed Description

This study aims to evaluate the validity of using informative SNPs to distinguish balanced from normal embryos. This will involve acquiring material from families to set phase for informative SNPs, evaluation of existing and new embryo SNP array data, and follow up analysis of children born after applying the procedure.

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

Retention

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
translocation carrier		balanced translocation carriers who have undergone IVF

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of correct predictions of normal vs. balanced ploidy status as compared to conventional karyotype		up to 12 months once pregnant

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with balanced translocations who have undergone IVF

Exclusion Criteria:

those who do not wish to know their child(s) karyotype

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with balanced translocations

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard T Scott, MD, HCLD	Reproductive Medicine Associates of New Jersey	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive Medicine Associates of New Jersey		Basking Ridge	New Jersey	07920	United States

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