- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00547781
Implantation Failure and PGD
March 30, 2012 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA
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).
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
250
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Valencia, Spain, 46117
- IVI Valencia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carmen Rubio, PhD, IVI Valencia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
October 22, 2007
First Submitted That Met QC Criteria
October 22, 2007
First Posted (Estimate)
October 23, 2007
Study Record Updates
Last Update Posted (Estimate)
April 2, 2012
Last Update Submitted That Met QC Criteria
March 30, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- VLC-JD-0704-307-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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