Implantation Failure and PGD

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, IVI VALENCIA
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 July 24, 2014