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

March 16, 2017 updated by: Reproductive Medicine Associates of New Jersey

Evaluation of the Accuracy of Predicting Normal or Carrier Status in Euploid Embryos Produced by Patients With Balanced Translocations

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Reproductive Medicine Associates of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with balanced translocations

Description

Inclusion Criteria:

  • patients with balanced translocations who have undergone IVF

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
translocation carrier
balanced translocation carriers who have undergone IVF

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reproductive Medicine Associates of New Jersey

Investigators

  • Principal Investigator: Richard T Scott, MD, HCLD, Reproductive Medicine Associates of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMA-2014-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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