NCT00454311

Brief Summary

The aim of this study is to evaluate the impact of the biopsy of one or two cells in a preimplantatation genetic diagnosis program (PGD) for the screening of aneuploidies. This prospective and randomized study will be performed at the Instituto Valenciano de Infertilidad in Valencia (Spain) in those patientes included in our clinical program. Our purpose is to optimize the methodology employed in our laboratory in order to guarantee optimal implantation and pregnancy rates without a detrimental effect on the accuracy and efficiency of the cytogenetic analysis. Patients will undergo and IVF cycle, embryo biopsy will be performed on day 3 embryos in two fashions: in some patients only one cell per embryo will be retrieved whereas in others, 2 cells will be retrieved in good morphology embryos and only 1 in the slowl ones. In all cases aneuploidy screening will be performed by FISH for chromosomes 13, 16, 18, 21, 22, X and Y. Embryo developmente will be checked every 24 hours and chormosomally normal embryos will be replaced into the uterus on day 5 of development.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable healthy

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

First Submitted

Initial submission to the registry

March 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 4, 2011

Status Verified

March 1, 2011

Enrollment Period

1.1 years

First QC Date

March 29, 2007

Last Update Submit

March 3, 2011

Conditions

Healthy

Keywords

Pregnancy and implantation ratesEfficiency and accuracy of the genetic testing

Outcome Measures

Primary Outcomes (1)

  • impact of biopsy

    8 days

Study Arms (2)

One cell biopsy

ACTIVE COMPARATOR
Procedure: · day embryo biopsy

Two cell biopsy

OTHER
Procedure: Biopsy of Day 3 Embryo

Interventions

Biopsy of Day 3 EmbryoPROCEDURE
Two cell biopsy
· day embryo biopsyPROCEDURE
One cell biopsy

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing PGD for aneuploidy screening with their own oocytes and for chromosomes 13, 16, 18, 21, 22, X \& Y

You may not qualify if:

  • Patients undergoing PGD for monogenic diseases (PCR)
  • Patients undergoing PGD for structural chromosomal abnormalities
  • Ovum donation cycles
  • Cryopreserved oocyte/embryos

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Valenciano de la Infertilidad

Valencia, 46015, Spain

Location

Study Officials

  • Carmen Rubio, PhD

    Instituto Valenciano de Infertilidad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2007

First Posted

March 30, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 4, 2011

Record last verified: 2011-03

Locations

ES(1)