Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases

Not Applicable

Withdrawn

• Conditions: Embryo Biopsy; Infertility
• Interventions: Other: Day 3 embryo biopsy; Other: Blastocyst biopsy

• Registration Number: NCT01950104
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-25
• Study Start: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Day 3 embryo biopsy	Day 3 embryo biopsy	Embryo biopsy is applied at day 3 of the embryo development
Blastocyst biopsy	Blastocyst biopsy	Embryo biopsy is applied at the blastocyst stage of the embryo development (day 5 or 6)

Primary Outcome Measures

Name	Time	Method
Live birth rate	20 months

Secondary Outcome Measures

Name	Time	Method
Fertilization rate	1 year
Embryo quality	1 year	Day 3 embryo quality
Implantation rate	1 year
Pregnancy rate	20 months

Trial Locations

Locations (1)

IVI Sevilla; 🇪🇸 Seville, Spain