NCT02178865

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

June 26, 2014

Last Update Submit

March 16, 2017

Conditions

Balanced Chromosomal Translocation

Keywords

translocation

Outcome Measures

Primary Outcomes (1)

  • Proportion of correct predictions of normal vs. balanced ploidy status as compared to conventional karyotype

    up to 12 months once pregnant

Study Arms (1)

translocation carrier

balanced translocation carriers who have undergone IVF

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with balanced translocations

You may qualify if:

  • patients with balanced translocations who have undergone IVF

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

buccal swabs and whole blood

Study Officials

  • Richard T Scott, MD, HCLD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

July 1, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2017

Last Updated

March 17, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)