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OpenTrials
Completed

NCT Number: NCT00593671

Preimplantation Genetic Screening in Women Over 35 Year

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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Key information

Conditions

In Vitro Fertilization

Age range

35 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leuven University Fertility Center

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preimplantation genetic screening after embryo biopsy

Procedure

Preimplantation genetic screening after embryo biopsy

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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Preimplantation Genetic Screening for Aneuploidy in Embryos After in Vitro Fertilization in Women Over 35: a Prospective Controlled Randomized Study.

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Jan 15, 2008
Registry last updated
Jan 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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