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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Aug 2015

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Same day study duration

First Submitted

Initial submission to the registry

September 23, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed

1.8 years until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed

Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed

Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

Same day

First QC Date

September 23, 2013

Last Update Submit

March 5, 2020

Conditions

Infertility Embryo Biopsy

Keywords

Embryo biopsyBlastocyst stageDay 3Preimplantation genetic screening

Outcome Measures

Primary Outcomes (1)

Live birth rate
20 months

Secondary Outcomes (4)

Fertilization rate
1 year
Embryo quality
1 year
Implantation rate
1 year
Pregnancy rate
20 months

Study Arms (2)