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:
Information provided by:
Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:
NCT00670059
First received: April 29, 2008
Last updated: April 30, 2008
Last verified: April 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670059

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Staessen Catherine Ph.D., UZBrussel
ClinicalTrials.gov Identifier: NCT00670059     History of Changes
Other Study ID Numbers: SET study
Study First Received: April 29, 2008
Last Updated: April 30, 2008
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Vrije Universiteit Brussel:
Single embryo transfer/ aneuploidy screening

ClinicalTrials.gov processed this record on April 17, 2014