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Preimplantation Genetic Screening in Women of Advanced Maternal Age

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00795795
Enrollment
640
Registered
2008-11-21
Start date
2008-12-31
Completion date
2011-12-31
Last updated
2012-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chromosomal Abnormalities

Keywords

Chromosomal abnormalities in preimplantation embryos

Brief summary

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.

Interventions

Preimplantation Genetic Screening

PROCEDUREIVF without PGS

IVF without PGS

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
38 Years to 44 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
ongoing implantation per embryo and per pacientone month

Secondary

MeasureTime frame
Take home baby9 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026