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NCT Number: NCT00795795

Preimplantation Genetic Screening in Women of Advanced Maternal Age

An increased incidence of aneuploid pregnancies has been reported in women of advanced maternal age, with higher miscarriage rates. Cytogenetic studies in preimplantation embryos have shown elevated aneuploidy rate, particularly in women over 38 years. For these reasons, PGS has been applied to these patients to improve ongoing implantation rates, and most importantly, to decrease the risk of further miscarriages and affected offspring. In the past two years, several RCT have raised the question whether PGS is benefitial or not in AMA patients.

In our experience, PGS outcome in these patients offers higher ongoing implantation rates than the previously published in RCT studies, where no benefits for PGS were found. In these papers, poor technical skills, as well as unclear patients selection could explain the reported lack of PGS benefits.

Therefore, the objective of the present RCT is to analyze the outcome of IVF cycles with and without PGS in two age groups:

* Patients 38-39 years of age: 200 cyles per arm reaching embryo transfer should be performed * Patients 40-44 years of age: 120 cycles per arm reaching embryo transfer Sample size has been calculated according to our retrospective experience with higher differences in ongoing implantation rates between cycles with and without PGS in patients of 40-44 years of age. In all patients embryo transfer will be performed on day 5. In the PGS group one cell will be biopsy in embryos with ≥5 cells on day-3 and chromosomes 13, 15, 17, 18, 21, 22, X and Y will be analyzed in two rounds. In the third round, nuclei with undoubtful or non-conclusive results will be analyzed using subtelomeric probes.

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Key information

Age range

38 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Valenciano de Infertilidad

Valencia, 46015, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female Patients over 37 years old, attending a fertility clinic

Exclusion criteria

  • Azoospermic partners
  • Female patients with uterine malformations
  • number of retreived oocytes below 5

Treatment and study plan

Preimplantation Genetic Screening

Procedure

Preimplantation Genetic Screening

IVF without PGS

Procedure

IVF without PGS

Primary outcomes

  1. ongoing implantation per embryo and per pacient

    Time frame: one month

Secondary outcomes

  1. Take home baby

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Official study title

Randomized Controlled Trial (RCT) of Preimplantation Genetic Screening (PGS) in Women of Advanced Maternal Age (AMA)

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 21, 2008
Registry last updated
Apr 2, 2012

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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