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Preimplantation Genetic Screening in Women Over 35 Year

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00593671
First Posted: January 15, 2008
Last Update Posted: January 15, 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:
Katholieke Universiteit Leuven
  Purpose

In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to improve success rates after IVF, we test the hypothesis that patients with advanced maternal age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally normal embryos following PGS compared to patients who had an ET without PGS.

In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without PGS.


Condition Intervention
In Vitro Fertilization Procedure: Preimplantation genetic screening after embryo biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Preimplantation Genetic Screening for Aneuploidy in Embryos After in Vitro Fertilization in Women Over 35: a Prospective Controlled Randomized Study.

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Clinical implantation rate per embryo transferred [ Time Frame: end of study ]

Secondary Outcome Measures:
  • Pregnancy rate per transfer [ Time Frame: end of study ]

Enrollment: 100
Study Start Date: June 2002
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PGS group Procedure: Preimplantation genetic screening after embryo biopsy
Preimplantation genetic screening after embryo biopsy
No Intervention: control group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All couples with a medical indication for IVF and with a female age of at least 35 years are invited to participate in the study.

Exclusion Criteria:

  • Cycles were excluded from the study if ≤ 2 fertilized oocytes were available on day 1 after oocyte retrieval (OR), or if ≤ 2 ≥ 6c stage embryos were available on day 3 after OR.
  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): NCT00593671


Locations
Belgium
Leuven University Fertility Center
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Study Director: Thomas M D'Hooghe, MD UZ Leuven
  More Information

Responsible Party: Thomas D'Hooghe, Leuven University Fertility Center
ClinicalTrials.gov Identifier: NCT00593671     History of Changes
Other Study ID Numbers: sdbroc0
First Submitted: January 4, 2008
First Posted: January 15, 2008
Last Update Posted: January 15, 2008
Last Verified: January 2008

Keywords provided by Katholieke Universiteit Leuven:
aneuploidies in 7 chromosomes increased with advanced maternal age