Preimplantation Genetic Screening in Women Over 35 Year

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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In Vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PGS group

Group Type ACTIVE_COMPARATOR

Preimplantation genetic screening after embryo biopsy

Intervention Type PROCEDURE

Preimplantation genetic screening after embryo biopsy

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preimplantation genetic screening after embryo biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes