Preimplantation Genetic Screening in Women Over 35 Year - Full Text View

Sponsored by:	Katholieke Universiteit Leuven
Information provided by:	Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00593671

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

MedlinePlus related topics: Genetic Testing

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Parallel Assignment
Official Title:	Preimplantation Genetic Screening for Aneuploidy in Embryos After in Vitro Fertilization in Women Over 35: a Prospective Controlled Randomized Study.

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:

Clinical implantation rate per embryo transferred [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pregnancy rate per transfer [ Time Frame: end of study ] [ Designated as safety issue: No ]

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
PGS group: Active Comparator	Procedure: Preimplantation genetic screening after embryo biopsy Preimplantation genetic screening after embryo biopsy
control group: No Intervention

Eligibility

Ages Eligible for Study:	35 Years to 45 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Leuven University Fertility Center ( Thomas D'Hooghe )
Study ID Numbers:	sdbroc0
Study First Received:	January 4, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00593671 History of Changes
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Katholieke Universiteit Leuven:

aneuploidies in 7 chromosomes increased with advanced maternal age

Study placed in the following topic categories:

Aneuploidy

ClinicalTrials.gov processed this record on May 07, 2009