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Pre-Implantation Genetic Screening in Women Under the Age of 36 Years With Single Embryo Transfer

This study has been terminated.
(At the first prespecified interim analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00670059
First Posted: May 1, 2008
Last Update Posted: May 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vrije Universiteit Brussel
  Purpose

BACKGROUND: Single-embryo transfer is a well-accepted strategy to avoid multiple pregnancies in an assisted reproductive technology programme. The selection of the embryo with the highest implantation potential is a crucial step. Besides the morphological quality and embryo kinetics up to the blastocyst stage, pre-implantation genetic screening (PGS) of aneuploidy has been advocated as an adjuvant approach by which to select the right embryo for transfer.

METHODS: Couples with a female partner younger than 36 years were randomly assigned to undergo transfer of a single blastocyst in a cycle with or without PGS using fluorescence in situ hybridization for the chromosomes X, Y, 13, 16, 18, 21 and 22.


Condition Intervention
Live Birth Delivery Rate Genetic: single embryo transfer without aneuploidy screening Genetic: single embryo transfer with aneuploidy screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Pre-Implantation Genetic Screening in Women Under the Age of 36 With Single-Embryo Transfer

Further study details as provided by Vrije Universiteit Brussel:

Primary Outcome Measures:
  • live born delivery rate [ Time Frame: at birth of the child ]

Secondary Outcome Measures:
  • Number of pregnancies obtained with or without pre-implantation genetic screening [ Time Frame: positive HCG ]

Enrollment: 240
Study Start Date: October 2004
Study Completion Date: February 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
group: single embryo transfer without aneuploidy screening
Genetic: single embryo transfer without aneuploidy screening
without aneuploidy testing for the chromosomes XY, 13, 16, 18, 21, 22
Experimental: B
group: single embryo transfer with aneuploidy screening
Genetic: single embryo transfer with aneuploidy screening
with aneuploidy testing for the chromosomes XY, 13, 16, 18, 21, 22

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ovulatory women undergoing infertility treatment
  • maternal age below 36 years
  • need for ICSI
  • motile sperm: more than 1x1000000 sperm cells/ml
  • both having a normal karyotype
  Contacts and Locations
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): NCT00670059


Locations
Belgium
Staessen C
Brussels, Belgium, 1090
Sponsors and Collaborators
Vrije Universiteit Brussel
  More Information