NCT00593671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

Enrollment Period

4.6 years

First QC Date

January 4, 2008

Last Update Submit

January 14, 2008

Conditions

In Vitro Fertilization

Keywords

aneuploidies in 7 chromosomes increased with advanced maternal age

Outcome Measures

Primary Outcomes (1)

  • Clinical implantation rate per embryo transferred

    end of study

Secondary Outcomes (1)

  • Pregnancy rate per transfer

    end of study

Study Arms (2)

PGS group

ACTIVE COMPARATOR
Procedure: Preimplantation genetic screening after embryo biopsy

control group

NO INTERVENTION

Interventions

Preimplantation genetic screening after embryo biopsyPROCEDURE

Preimplantation genetic screening after embryo biopsy

PGS group

Eligibility Criteria

Age35 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leuven University Fertility Center

Leuven, 3000, Belgium

Location

Study Officials

  • Thomas M D'Hooghe, MD

    UZ Leuven

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 15, 2008

Study Start

June 1, 2002

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

BE(1)