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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Recruitment Status : Withdrawn (No started, lack of funding)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

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.


Condition or disease Intervention/treatment Phase
Infertility Embryo Biopsy Other: Day 3 embryo biopsy Other: Blastocyst biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparative Study Between Day 3 Embryo Biopsy and Blastocyst Biopsy in Preimplantation Genetic Screening Cases
Actual Study Start Date : August 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: Day 3 embryo biopsy
Embryo biopsy is applied at day 3 of the embryo development
Other: Day 3 embryo biopsy
Embryo biopsy is applied at day 3 of the embryo development.

Experimental: Blastocyst biopsy
Embryo biopsy is applied at the blastocyst stage of the embryo development (day 5 or 6)
Other: Blastocyst biopsy
Embryo biopsy is applied at the blastocyst stage of the embryo development




Primary Outcome Measures :
  1. Live birth rate [ Time Frame: 20 months ]

Secondary Outcome Measures :
  1. Fertilization rate [ Time Frame: 1 year ]
  2. Embryo quality [ Time Frame: 1 year ]
    Day 3 embryo quality

  3. Implantation rate [ Time Frame: 1 year ]
  4. Pregnancy rate [ Time Frame: 20 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950104


Locations
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Spain
IVI Sevilla
Seville, Spain, 41006
Sponsors and Collaborators
IVI Sevilla

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Responsible Party: IVI Sevilla
ClinicalTrials.gov Identifier: NCT01950104    
Other Study ID Numbers: IVISEV-005VINCI
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Keywords provided by IVI Sevilla:
Embryo biopsy
Blastocyst stage
Day 3
Preimplantation genetic screening
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female