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

NCT01332643 | Terminated Phase 3 DMC

• 1 other identifier: Reprogenetics-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Infertility; Miscarriage

Keywords

Preimplantation Genetic Diagnosis; recurrent pregnancy loss; infertility; genetic screening; trisomy 21; Down syndrome

Outcome Measures

Primary Outcomes (1)

• Implantation rate

  number of embryos implanted divided by number of embryos replaced. An embryo implanted is measured as a fetal sac by ultrasound observation.

  three weeks after embryo replacement

Secondary Outcomes (4)

• miscarriage rate

  up to the end of second trimester

• Pregnancy rate per transfer

  three weeks after implantation

• Pregnancy rate per retrieval

  three weeks after transfer

• live birth rate

  1 year after embryo transfer

Study Arms (2)

Test

ACTIVE COMPARATOR

The test group will consist of patients undergoing blastocyst biopsy followed by vitrification (embryo freezing), and in which the biopsied cells will be analyzed with a comprehensive chromosome analysis technique (array Comparative Genome hybridization or aCGH) and only one chromosomally normal embryo will be replaced in a thawed cycle.

Genetic: Preimplantation Genetic Diagnosis

control

NO INTERVENTION

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. If patient does not become pregnant, successive embryo transfers of frozen embryos will be performed, but not as part of the study.

Interventions

Preimplantation Genetic Diagnosis GENETIC

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.

Also known as: array CGH from Bluegnome, UK

Test

Eligibility Criteria

• Age: 30 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Couples with women 30-42 years of age
• Follicle Stimulating Hormone (FSH) level \<11IU/L on day 3 of cycle.

You may not qualify if:

• TESA and TESE patients
• Couples' carriers of chromosomal or genetic diseases
• Couples that produce less than eight antral follicles on day 2-4 of cycle
• Patients will be excluded if they produce no blastocysts by day 5

Sponsors & Collaborators

• Reprogenetics: lead
• Reprogenetics Lationoamerica S.A.C, Lima, Peru: collaborator
• Pranor S.R.L., Lima, Peru: collaborator
• Yale University: collaborator
• McGill University: collaborator

Study Sites (1)

Pranor

Lima, Lima Province, Peru

Location

Related Publications (3)

• Gutierrez-Mateo C, Colls P, Sanchez-Garcia J, Escudero T, Prates R, Ketterson K, Wells D, Munne S. Validation of microarray comparative genomic hybridization for comprehensive chromosome analysis of embryos. Fertil Steril. 2011 Mar 1;95(3):953-8. doi: 10.1016/j.fertnstert.2010.09.010. Epub 2010 Oct 25.

  PMID: 20971462 BACKGROUND

• Schoolcraft WB, Fragouli E, Stevens J, Munne S, Katz-Jaffe MG, Wells D. Clinical application of comprehensive chromosomal screening at the blastocyst stage. Fertil Steril. 2010 Oct;94(5):1700-6. doi: 10.1016/j.fertnstert.2009.10.015. Epub 2009 Nov 25.

  PMID: 19939370 BACKGROUND

• Munne S, Wells D, Cohen J. Technology requirements for preimplantation genetic diagnosis to improve assisted reproduction outcomes. Fertil Steril. 2010 Jul;94(2):408-30. doi: 10.1016/j.fertnstert.2009.02.091. Epub 2009 May 5.

  PMID: 19409550 BACKGROUND

MeSH Terms

Conditions

Infertility; Abortion, Spontaneous; Down Syndrome

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Santiago Munne, PhD

  Reprogenetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 30, 2012

Record last verified: 2012-05

Locations

PE (1)