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

December 22, 2016 updated by: Marta Devesa, Institut Universitari Dexeus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08037
        • Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Repeated implantation failure patients: patients <39 years old that have received at least 4 day 3 good quality embryos or 2 good quality blastocists with no implantation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PGS
Patients with RIF scheduled for PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridation (aCGH) underwent one or more stimulation cycles. If euploid blastocysts were available, patients underwent frozen embryo transfer/s.
Procedure: PGS (Preimplantation Genetic Screening) with trophectoderm biopsy
PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridizatioon (aCGH)
Standard IVF
Patients with RIF scheduled for standard IVF (In Vitro Fertilization) underwent a single stimulation cycle with the fresh embryo transfer and the subsequent frozen embryo transfers if there were surplus frozen embryos and the fresh embryo transfer was unsuccessful.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative live birth rate
Time Frame: at 24 months of first embryo transfer
at 24 months of first embryo transfer

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Pregnancy Rate
Time Frame: 6 weeks after embryo transfer
6 weeks after embryo transfer
Implantation Rate
Time Frame: 6 weeks after embryo transfer
6 weeks after embryo transfer
Miscarriage Rate
Time Frame: Until 20 weeks after embryo transfer
Until 20 weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 23, 2016

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMD-DEX-2016-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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