Preimplantation Genetic Screening in Women Over 35 Year

In Vitro Fertilization Clinical Trial

Official title:

Preimplantation Genetic Screening for Aneuploidy in Embryos After in Vitro Fertilization in Women Over 35: a Prospective Controlled Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593671
• Other study ID #: sdbroc0
• Status: Completed
• Phase: N/A
• First received: January 4, 2008
• Last updated: January 14, 2008
• Start date: June 2002
• Est. completion date: January 2007

Study information

• Verified date: January 2008
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial Summary

In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to improve success rates after IVF, we test the hypothesis that patients with advanced maternal age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally normal embryos following PGS compared to patients who had an ET without PGS.

In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without PGS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria:

• All couples with a medical indication for IVF and with a female age of at least 35 years are invited to participate in the study.

Exclusion Criteria:

• Cycles were excluded from the study if = 2 fertilized oocytes were available on day 1 after oocyte retrieval (OR), or if = 2 = 6c stage embryos were available on day 3 after OR.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• In Vitro Fertilization

Intervention

Procedure:
• Preimplantation genetic screening after embryo biopsy
Preimplantation genetic screening after embryo biopsy

Locations

Country	Name	City	State
Belgium	Leuven University Fertility Center	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical implantation rate per embryo transferred		end of study	No
Secondary	Pregnancy rate per transfer		end of study	No