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Preimplantation Genetic Screening in Women Over 35 Year

This study has been completed.
Information provided by:
Katholieke Universiteit Leuven Identifier:
First received: January 4, 2008
Last updated: January 14, 2008
Last verified: January 2008

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


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

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
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 identifier: NCT00593671

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

Responsible Party: Thomas D'Hooghe, Leuven University Fertility Center Identifier: NCT00593671     History of Changes
Other Study ID Numbers: sdbroc0
Study First Received: January 4, 2008
Last Updated: January 14, 2008

Keywords provided by Katholieke Universiteit Leuven:
aneuploidies in 7 chromosomes increased with advanced maternal age processed this record on September 21, 2017