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Implantation Failure and PGD

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ClinicalTrials.gov Identifier: NCT00547781
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : April 2, 2012
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary:
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 or disease Intervention/treatment Phase
IMPLANTATION Procedure: PGD Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : July 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Carmen Rubio, IVI Valencia
ClinicalTrials.gov Identifier: NCT00547781     History of Changes
Other Study ID Numbers: VLC-JD-0704-307-12
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012