Implantation Failure and PGD

NCT ID: NCT00547781

Last Updated: 2012-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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IMPLANTATION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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PGD

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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IVI Valencia

Principal Investigators

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Carmen Rubio, PhD

Role: PRINCIPAL_INVESTIGATOR

IVI Valencia

Locations

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IVI Valencia

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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VLC-JD-0704-307-12

Identifier Type: -

Identifier Source: org_study_id

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