Preimplantation Genetic Screening in Women of Advanced Maternal Age

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)

Overall Status

Completed

CT.gov ID

NCT00795795

Collaborator

(none)

640

Enrollment

Location

Arms

Duration (Months)

17.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chromosomal Abnormalities	Procedure: Preimplantation Genetic Screening Procedure: IVF without PGS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

640 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: with PGS IVF cycles with Preimplantation Genetic Screening (PGS)	Procedure: Preimplantation Genetic Screening Preimplantation Genetic Screening
Active Comparator: Without PGS IVF cycle without Preimplantation Genetic Screening	Procedure: Preimplantation Genetic Screening Preimplantation Genetic Screening Procedure: IVF without PGS IVF without PGS

Arm

Intervention/Treatment

Active Comparator: with PGS

IVF cycles with Preimplantation Genetic Screening (PGS)

Procedure: Preimplantation Genetic Screening

Preimplantation Genetic Screening

Active Comparator: Without PGS

IVF cycle without Preimplantation Genetic Screening

Procedure: Preimplantation Genetic Screening

Preimplantation Genetic Screening

Procedure: IVF without PGS

IVF without PGS

Outcome Measures

Primary Outcome Measures

ongoing implantation per embryo and per pacient [one month]

Secondary Outcome Measures

Take home baby [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

38 Years to 44 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Valenciano de Infertilidad	Valencia		Spain	46015

Sponsors and Collaborators

Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00795795

Other Study ID Numbers:

0802-C-046-CR

First Posted:

Nov 21, 2008

Last Update Posted:

Apr 2, 2012

Last Verified:

Mar 1, 2012

Keywords provided by , ,

Chromosomal abnormalities in preimplantation embryos

Additional relevant MeSH terms:

Congenital Abnormalities

Chromosome Disorders

Chromosome Aberrations

Study Results

No Results Posted as of Apr 2, 2012