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Implantation Failure and PGD

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT00547781
First received: October 22, 2007
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  Purpose

The aim of this study is to performed a randomized controlled trial to evaluate the usefulness of preimplantation genetic diagnosis (PGD) in patients with repetitive implantation failure. Patients will be prospectively randomized in two groups: standard IVF with blastocyst transfer on day-5 and transfer day-5 after PGD for aneuploidy screening for chromosomes 13, 15, 16, 18, 21, 22, X and Y. The end points of the study are: Cancellation rate; implantation rate and ongoing implantation rate. Inclusion criteria are: patients with ≥2 previous IVF failure without clinical or biochemical pregnancy with transfer of at least 2 good quality embryos per transfer. Exclusion criteria will be uterine abnormalities , abnormal karyotypes, abnormal result in thrombophilia screening and low responder patients (less than 4 expected oocytes).


Condition Intervention Phase
IMPLANTATION
 Procedure: PGD
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Estimated Enrollment: 250
Study Start Date: July 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients of any age with ≥2 previous cycles, negative TIG or biochemical pregnancy with fresh transfer of at least 2 embryos in each cycle.

Exclusion Criteria:

  • Patients with PGD indication (age, repetitive miscarriage, chromosomal anomalies, etc. )
  • Patients with ectopic pregnancies in previous cycles.
  • Recipient of oocyte donation.
  • Patients in which 4 or less oocytes are to be retrieved.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547781

Locations
Spain
IVI Valencia
Valencia, Spain, 46117
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Principal Investigator: Carmen Rubio, PhD IVI Valencia
  More Information

No publications provided

Responsible Party: Dr. Carmen Rubio, IVI Valencia
ClinicalTrials.gov Identifier: NCT00547781     History of Changes
Other Study ID Numbers: VLC-JD-0704-307-12
Study First Received: October 22, 2007
Last Updated: March 30, 2012
Health Authority: Spain: Centro Coordinador de Comités Éticos

ClinicalTrials.gov processed this record on May 16, 2013