Implantation Failure and PGD

IMPLANTATION Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547781
• Other study ID #: VLC-JD-0704-307-12
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2007
• Last updated: March 30, 2012
• Start date: July 2007
• Est. completion date: January 2012

Study information

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

Clinical Trial Summary

The aim of this study is to performed a randomized controlled trial to evaluate the usefulness of preimplantation genetic diagnosis (PGD) in patients with repetitive implantation failure. Patients will be prospectively randomized in two groups: standard IVF with blastocyst transfer on day-5 and transfer day-5 after PGD for aneuploidy screening for chromosomes 13, 15, 16, 18, 21, 22, X and Y. The end points of the study are: Cancellation rate; implantation rate and ongoing implantation rate. Inclusion criteria are: patients with ≥2 previous IVF failure without clinical or biochemical pregnancy with transfer of at least 2 good quality embryos per transfer. Exclusion criteria will be uterine abnormalities , abnormal karyotypes, abnormal result in thrombophilia screening and low responder patients (less than 4 expected oocytes).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of any age with =2 previous cycles, negative TIG or biochemical pregnancy with fresh transfer of at least 2 embryos in each cycle.

Exclusion Criteria:

• Patients with PGD indication (age, repetitive miscarriage, chromosomal anomalies, etc. )

• Patients with ectopic pregnancies in previous cycles.

• Recipient of oocyte donation.

• Patients in which 4 or less oocytes are to be retrieved.

Study Design

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

Related Conditions & MeSH terms

• IMPLANTATION

Intervention

Procedure:
• PGD

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain,