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OpenTrials
Completed

NCT Number: NCT03001648

Cumulative Live Birth Rates in Patients With Repeated Implantation Failure (RIF) Undergoing Preimplantation Genetic Screening (PGS )

This is a single centre retrospective study in repeated implantation failure patients: < 39 years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred without implantation, absence of known causes of implantation failures (uterine malformation, thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease).

Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally. Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to standard IVF cycles.

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Key information

Conditions

Infertility Genital Diseases Preimplantation Genetic Screening Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, 08037, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women < 39 years
  • repeated implantation failure: at least 4 day 3 good quality embryos or 2 good quality blastocysts transferred without implantation

Exclusion criteria

  • partner with severe male factor, or abnormal sperm Fluorescence in situ hybridization (FISH) analysis
  • presence of uni or bilateral hydrosalpinx, uterine malformation, thrombophilia, uncontrolled thyroid disfunction or autoimmune disease

Treatment and study plan

PGS (Preimplantation Genetic Screening) with trophectoderm biopsy

Procedure

PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridizatioon (aCGH)

Primary outcomes

  1. Cumulative live birth rate

    Time frame: at 24 months of first embryo transfer

Secondary outcomes

  1. Clinical Pregnancy Rate

    Time frame: 6 weeks after embryo transfer

  2. Implantation Rate

    Time frame: 6 weeks after embryo transfer

  3. Miscarriage Rate

    Time frame: Until 20 weeks after embryo transfer

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2016
Registry last updated
Dec 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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