Back to resultsPreimplantation Genetic Screening in Women Over 35 Year
Primary Purpose
In Vitro Fertilization
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Preimplantation genetic screening after embryo biopsy
Sponsored by
About this trial
This is an interventional basic science trial for In Vitro Fertilization focused on measuring aneuploidies in 7 chromosomes increased with advanced maternal age
Eligibility 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.
Sites / Locations
- Leuven University Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
PGS group
control group
Arm Description
Outcomes
Primary Outcome Measures
Clinical implantation rate per embryo transferred
Secondary Outcome Measures
Pregnancy rate per transfer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00593671
Brief Title
Preimplantation Genetic Screening in Women Over 35 Year
Official Title
Preimplantation Genetic Screening for Aneuploidy in Embryos After in Vitro Fertilization in Women Over 35: a Prospective Controlled Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
In Vitro Fertilization
Keywords
aneuploidies in 7 chromosomes increased with advanced maternal age
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PGS group
Arm Type
Active Comparator
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Preimplantation genetic screening after embryo biopsy
Intervention Description
Preimplantation genetic screening after embryo biopsy
Primary Outcome Measure Information:
Title
Clinical implantation rate per embryo transferred
Time Frame
end of study
Secondary Outcome Measure Information:
Title
Pregnancy rate per transfer
Time Frame
end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M D'Hooghe, MD
Organizational Affiliation
UZ Leuven
Official's Role
Study Director
Facility Information:
Facility Name
Leuven University Fertility Center
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
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Preimplantation Genetic Screening in Women Over 35 Year
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