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

NCT03001648 | Completed

• 1 other identifier: SMD-DEX-2016-02
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility; Preimplantation Genetic Screening

Outcome Measures

Primary Outcomes (1)

• Cumulative live birth rate

  at 24 months of first embryo transfer

Secondary Outcomes (3)

• Clinical Pregnancy Rate

  6 weeks after embryo transfer

• Implantation Rate

  6 weeks after embryo transfer

• Miscarriage Rate

  Until 20 weeks after embryo transfer

Study Arms (2)

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

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.

Interventions

PGS (Preimplantation Genetic Screening) with trophectoderm biopsy PROCEDURE

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

PGS

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Dexeus: lead

Study Sites (1)

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, Barcelona, 08037, Spain

Location

MeSH Terms

Conditions

Infertility

Interventions

Phosphatidylglycerols

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff member of Reproductive Unit

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 23, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 23, 2016

Record last verified: 2016-12

Locations

ES (1)