Preimplantation Genetic Screening in Women of Advanced Maternal Age

NCT00795795 | Completed

• 1 other identifier: 0802-C-046-CR
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

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.

Conditions

Chromosomal Abnormalities

Keywords

Chromosomal abnormalities in preimplantation embryos

Outcome Measures

Primary Outcomes (1)

• ongoing implantation per embryo and per pacient

  one month

Secondary Outcomes (1)

• Take home baby

  9 months

Study Arms (2)

with PGS

ACTIVE COMPARATOR

IVF cycles with Preimplantation Genetic Screening (PGS)

Procedure: Preimplantation Genetic Screening

Without PGS

ACTIVE COMPARATOR

IVF cycle without Preimplantation Genetic Screening

Procedure: Preimplantation Genetic Screening; Procedure: IVF without PGS

Interventions

Preimplantation Genetic Screening PROCEDURE

Preimplantation Genetic Screening

Without PGS; with PGS

IVF without PGS PROCEDURE

IVF without PGS

Without PGS

Eligibility Criteria

• Age: 38 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

Instituto Valenciano de Infertilidad

Valencia, Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Chromosome Aberrations

Interventions

Phosphatidylglycerols

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 2, 2012

Record last verified: 2012-03

Locations

ES (1)