Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases (VINCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950104
Recruitment Status : Withdrawn (No started, lack of funding)
First Posted : September 25, 2013
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
IVI Sevilla

Tracking Information
First Submitted Date  ICMJE September 23, 2013
First Posted Date  ICMJE September 25, 2013
Last Update Posted Date March 6, 2020
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
Live birth rate [ Time Frame: 20 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
  • Fertilization rate [ Time Frame: 1 year ]
  • Embryo quality [ Time Frame: 1 year ]
    Day 3 embryo quality
  • Implantation rate [ Time Frame: 1 year ]
  • Pregnancy rate [ Time Frame: 20 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases
Official Title  ICMJE Comparative Study Between Day 3 Embryo Biopsy and Blastocyst Biopsy in Preimplantation Genetic Screening Cases
Brief Summary

Preimplantation genetic diagnosis (PGS) is a technique that allow us to improve the results of assisted reproduction techniques through the selection of embryos free of chromosomal abnormalities.

At present, it has not been proved that the usage of PGS really improves the live birth rate in IVF cycles. However, it has been stated that the reason of not having better results when using PGS is that the methodology applied is not adequate.

Several authors propose that the optimal methodology for PGS includes the application of comparative genomic hybridization (CGH) arrays for genetic testing and carrying out embryo biopsy at the blastocyst stage. Nevertheless, most IVF centres still applies the day 3 embryo biopsy as a daily routine. Despite this fact, there is a gradual transition towards the usage of blastocyst-stage biopsy instead of day 3 biopsy.

The purpose of this clinical study is analysing the results of the IVF cycles with embryo biopsy for PGS. Live birth rates and other parameters as the pregnancy and implantation rates together with embryo quality will be analysed and compared between two groups of patients undergoing IVF cycles with PGS. In one group the biopsy will be applied in day 3 of the embryo development, while in the other group the embryo biopsy will be fulfilled at the blastocyst stage.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Infertility
  • Embryo Biopsy
Intervention  ICMJE
  • Other: Day 3 embryo biopsy
    Embryo biopsy is applied at day 3 of the embryo development.
  • Other: Blastocyst biopsy
    Embryo biopsy is applied at the blastocyst stage of the embryo development
Study Arms  ICMJE
  • Active Comparator: Day 3 embryo biopsy
    Embryo biopsy is applied at day 3 of the embryo development
    Intervention: Other: Day 3 embryo biopsy
  • Experimental: Blastocyst biopsy
    Embryo biopsy is applied at the blastocyst stage of the embryo development (day 5 or 6)
    Intervention: Other: Blastocyst biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 4, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2013)
150
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients under 49 years undergoing IVF cycles with PGS for one of the following reasons:

  • Advanced maternal age
  • Recurrent implantation failure
  • Recurrent abortion
  • Severe male-factor infertility

Exclusion Criteria:

  • Not being able to sign the informed consent to participate in the study
  • Patients undergoing preimplantation genetic diagnosis
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01950104
Other Study ID Numbers  ICMJE IVISEV-005VINCI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IVI Sevilla
Study Sponsor  ICMJE IVI Sevilla
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IVI Sevilla
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP