Preimplantation Genetic Screening in Women of Advanced Maternal Age

Not Applicable

Completed

• Conditions: Chromosomal Abnormalities
• Interventions: Procedure: Preimplantation Genetic Screening; Procedure: IVF without PGS

• Registration Number: NCT00795795
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Study Start: 2008-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-30
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 640

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with PGS	Preimplantation Genetic Screening	IVF cycles with Preimplantation Genetic Screening (PGS)
Without PGS	Preimplantation Genetic Screening	IVF cycle without Preimplantation Genetic Screening
Without PGS	IVF without PGS	IVF cycle without Preimplantation Genetic Screening

Primary Outcome Measures

Name	Time	Method
ongoing implantation per embryo and per pacient	one month

Secondary Outcome Measures

Name	Time	Method
Take home baby	9 months

Trial Locations

Locations (1)

Instituto Valenciano de Infertilidad; 🇪🇸 Valencia, Spain