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Withdrawn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
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
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
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Withdrawn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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