Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility, Embryo Biopsy

Intervention / Treatment
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* Other: Day 3 embryo biopsy
* Other: Blastocyst biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Day 3 embryo biopsy<br>Embryo biopsy is applied at day 3 of the embryo development | Other: Day 3 embryo biopsy<br>* Embryo biopsy is applied at day 3 of the embryo development.<br>|
| Experimental: Blastocyst biopsy<br>Embryo biopsy is applied at the blastocyst stage of the embryo development (day 5 or 6) | Other: Blastocyst biopsy<br>* Embryo biopsy is applied at the blastocyst stage of the embryo development<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate |  | 20 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate |  | 1 year | 
| Embryo quality | Day 3 embryo quality | 1 year | 
| Implantation rate |  | 1 year | 
| Pregnancy rate |  | 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embryo biopsy, Blastocyst stage, Day 3, Preimplantation genetic screening