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CompletedNCT00593671Updated Jan 15, 2008

Preimplantation Genetic Screening in Women Over 35 Year

An interventional study of Preimplantation genetic screening after embryo biopsy in In Vitro Fertilization, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 35 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-15.

Sponsored by KU Leuven · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
35 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • In Vitro Fertilization

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Keywords

  • aneuploidies in 7 chromosomes increased with advanced maternal age
03

In context

Aneuploidy

87 studies on the registry are indexed under Aneuploidy; 12 are open to participants now.

This study's enrollment of 100 is below the median of 152 across 36 interventional studies indexed under Aneuploidy.

Browse Aneuploidy studies →

Lead sponsor

KU Leuven is the lead sponsor of 358 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    PGS group

    Procedure: Preimplantation genetic screening after embryo biopsy

  • No intervention
    control group

Interventions

  • ProcedurePreimplantation genetic screening after embryo biopsy

    Preimplantation genetic screening after embryo biopsy

06

What researchers measure

Primary outcomes

  1. Clinical implantation rate per embryo transferred

    Time frame: end of study

Secondary outcomes

  1. Pregnancy rate per transfer

    Time frame: end of study

07

Study locations

1 site
  • Leuven University Fertility Center
    Leuven, 3000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00593671
Lead sponsor
KU Leuven
First posted
Jan 15, 2008
Start date
Jun 2002
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Jan 15, 2008

Study contacts

Thomas M D'Hooghe, MD
study director · UZ Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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