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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00593671
Other study ID # sdbroc0
Secondary ID
Status Completed
Phase N/A
First received January 4, 2008
Last updated January 14, 2008
Start date June 2002
Est. completion date January 2007

Study information

Verified date January 2008
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Procedure:
Preimplantation genetic screening after embryo biopsy
Preimplantation genetic screening after embryo biopsy

Locations

Country Name City State
Belgium Leuven University Fertility Center Leuven

Sponsors (1)

Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical implantation rate per embryo transferred end of study No
Secondary Pregnancy rate per transfer end of study No
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