Preimplantation Genetic Screening in Women of Advanced Maternal Age

Chromosomal Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795795
• Other study ID #: 0802-C-046-CR
• Status: Completed
• Phase: N/A
• First received: November 20, 2008
• Last updated: March 30, 2012
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 38 Years to 44 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chromosomal Abnormalities
• Chromosome Aberrations
• Chromosome Disorders
• Congenital Abnormalities

Intervention

Procedure:
• Preimplantation Genetic Screening
Preimplantation Genetic Screening
• IVF without PGS
IVF without PGS

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ongoing implantation per embryo and per pacient		one month	No
Secondary	Take home baby		9 months	No