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Implantation Failure and PGD

I

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase

Completed
Phase 4

Conditions

IMPLANTATION

Treatments

Procedure: PGD

Study type

Interventional

Funder types

Other

Identifiers

NCT00547781
VLC-JD-0704-307-12

Details and patient eligibility

About

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).

Enrollment

250 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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