NCT00547781

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

4.5 years

First QC Date

October 22, 2007

Last Update Submit

March 30, 2012

Conditions

IMPLANTATION

Interventions

PGDPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, Valencia, 46117, Spain

Location

MeSH Terms

Interventions

Prostaglandins D

Intervention Hierarchy (Ancestors)

ProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Carmen Rubio, PhD

    IVI Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 23, 2007

Study Start

July 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 2, 2012

Record last verified: 2012-03

Locations

ES(1)