Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases

Infertility Clinical Trial

— VINCI  

Official title:

Comparative Study Between Day 3 Embryo Biopsy and Blastocyst Biopsy in Preimplantation Genetic Screening Cases

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01950104
• Other study ID #: IVISEV-005VINCI
• Status: Withdrawn
• Phase: N/A
• Start date: August 2015
• Est. completion date: August 2015

Study information

• Verified date: March 2020
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Embryo Biopsy
• Infertility

Intervention

Other:
• Day 3 embryo biopsy
Embryo biopsy is applied at day 3 of the embryo development.
• Blastocyst biopsy
Embryo biopsy is applied at the blastocyst stage of the embryo development

Locations

Country	Name	City	State
Spain	IVI Sevilla	Seville

Sponsors (1)

Lead Sponsor	Collaborator
IVI Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate		20 months
Secondary	Fertilization rate		1 year
Secondary	Embryo quality	Day 3 embryo quality	1 year
Secondary	Implantation rate		1 year
Secondary	Pregnancy rate		20 months