Preimplantation Genetic Screening in Women of Advanced Maternal Age

NCT ID: NCT00795795

Last Updated: 2012-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

with PGS

IVF cycles with Preimplantation Genetic Screening (PGS)

Group Type: ACTIVE_COMPARATOR

Preimplantation Genetic Screening

Intervention Type: PROCEDURE

Preimplantation Genetic Screening

Without PGS

IVF cycle without Preimplantation Genetic Screening

Group Type: ACTIVE_COMPARATOR

Preimplantation Genetic Screening

Intervention Type: PROCEDURE

Preimplantation Genetic Screening

IVF without PGS

Intervention Type: PROCEDURE

IVF without PGS

Interventions

Preimplantation Genetic Screening

Preimplantation Genetic Screening

Intervention Type: PROCEDURE

IVF without PGS

IVF without PGS

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 38 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: lead

Responsible Party

Instituto Valenciano de Infertilidad

Locations

Instituto Valenciano de Infertilidad

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

0802-C-046-CR

Identifier Type: -

Identifier Source: org_study_id