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

Primary Purpose

Infertility, Embryo Biopsy

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Day 3 embryo biopsy
Blastocyst biopsy
Sponsored by
IVI Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility focused on measuring Embryo biopsy, Blastocyst stage, Day 3, Preimplantation genetic screening

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • IVI Sevilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Day 3 embryo biopsy

Blastocyst biopsy

Arm Description

Embryo biopsy is applied at day 3 of the embryo development

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

Outcomes

Primary Outcome Measures

Live birth rate

Secondary Outcome Measures

Fertilization rate
Embryo quality
Day 3 embryo quality
Implantation rate
Pregnancy rate

Full Information

First Posted
September 23, 2013
Last Updated
March 5, 2020
Sponsor
IVI Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT01950104
Brief Title
Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases
Acronym
VINCI
Official Title
Comparative Study Between Day 3 Embryo Biopsy and Blastocyst Biopsy in Preimplantation Genetic Screening Cases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No started, lack of funding
Study Start Date
August 2015 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVI Sevilla

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Embryo Biopsy
Keywords
Embryo biopsy, Blastocyst stage, Day 3, Preimplantation genetic screening

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Day 3 embryo biopsy
Arm Type
Active Comparator
Arm Description
Embryo biopsy is applied at day 3 of the embryo development
Arm Title
Blastocyst biopsy
Arm Type
Experimental
Arm Description
Embryo biopsy is applied at the blastocyst stage of the embryo development (day 5 or 6)
Intervention Type
Other
Intervention Name(s)
Day 3 embryo biopsy
Intervention Description
Embryo biopsy is applied at day 3 of the embryo development.
Intervention Type
Other
Intervention Name(s)
Blastocyst biopsy
Intervention Description
Embryo biopsy is applied at the blastocyst stage of the embryo development
Primary Outcome Measure Information:
Title
Live birth rate
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Fertilization rate
Time Frame
1 year
Title
Embryo quality
Description
Day 3 embryo quality
Time Frame
1 year
Title
Implantation rate
Time Frame
1 year
Title
Pregnancy rate
Time Frame
20 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
IVI Sevilla
City
Seville
ZIP/Postal Code
41006
Country
Spain

12. IPD Sharing Statement

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Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases

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