MedTrace Logo

Preimplantation Genetic Diagnosis (PGD) by Array Comparative Genome Hybridization (CGH) and Blastocyst Biopsy

NCT01332643 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-05-30

No results posted yet for this study

Summary

This study evaluates the effect of single embryo transfer (SET) with and without array CGH for the evaluation of the complete chromosome complement of the blastocyst. Patients will be allocated at random into two groups. The control group will consist of patients in which one embryo will be replaced on day 5 based on morphological and developmental characteristics, and the other embryos reaching blastocyst stage will be vitrified. The test group will consist of patients undergoing embryo biopsy at the blastocyst stage (day 5 of development, embryo freezing, and analysis of the biopsied cells with a comprehensive chromosome analysis technique (array Comparative Genome hybridization or aCGH). Only a chromosomally normal blastocyst will be replaced in a thawed cycle. Inclusion and exclusion criteria are described in the study population section.

Conditions

Interventions

GENETIC

Preimplantation Genetic Diagnosis

All embryos in the test group reaching blastocyst stage will undergo embryo biopsy of 3-10 trophectoderm cells. The cells will be analyzed by array CGH to detect the presence or not of chromosome abnormalities. The embryos will be vitrified and those classified by array CGH as normal, thawed for replacement.

Sponsors & Collaborators

  • Reprogenetics Lationoamerica S.A.C, Lima, Peru

    collaborator UNKNOWN

  • Pranor S.R.L., Lima, Peru

    collaborator UNKNOWN

  • Yale University

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • Reprogenetics

    lead INDUSTRY

Principal Investigators

  • Santiago Munne, PhD · Reprogenetics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • Peru

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01332643 on ClinicalTrials.gov