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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:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014