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

Balanced Chromosomal Translocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178865
• Other study ID #: RMA-2014-01
• Status: Completed
• Phase: N/A
• First received: June 26, 2014
• Last updated: March 16, 2017
• Start date: June 2014
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• patients with balanced translocations who have undergone IVF

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Balanced Chromosomal Translocation

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of correct predictions of normal vs. balanced ploidy status as compared to conventional karyotype		up to 12 months once pregnant