Invasive PGT-A Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection

Study Overview
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Brief Summary
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This is a prospective randomised study of the evaluation of the clinical IVF results after invasive PGT-A embryo selection versus Non-invasive PGT-A assisted embryo selection in subfertile women.

Detailed Description
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A randomized prospective study focusing on subfertile women undergoing IVF treatment followed by embryo transfer on the blastocyst stage. Women assigned to group A proceed to embryo transfer, after invasive PGT-A embryo selection, while women of group B after non-invasive PGT-A assisted embryo selection. IVF outcomes, regarding the success rate of the trasnfer and the time required to achieve conception is studied in both groups.

Official Title
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IVF Outcomes Based on Invasive PGT-A Embryo Selection Versus Non Invasive PGT-A Assisted

Conditions
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Infertility, Aneuploidy, Chromosome Abnormality

Intervention / Treatment
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* Diagnostic Test: embryo selection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who followed IVF treatment 40 years old or older Single embryo transfer blastocyst stage cultured embryos Exclusion Criteria: women under the age of 40 years not blastocyst transfer (transfers performed at earlier embryo stage) double embryotransfer women who had embryotransfer according to morphological criteria women whose embryos were not time-lapse monitored

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| INVASIVE PGT-A<br>Women who proceed to embryo transfer after invasive PGT-A embryo selection. | Diagnostic Test: embryo selection<br>* The basis of embryo selection for transfer: invasive PGT-A or after non-invasive PGT-A<br>|
| NON INVASIVE PGT-A<br>Women who proceed to embryo transfer after non- invasive PGT-A embryo selection. | Diagnostic Test: embryo selection<br>* The basis of embryo selection for transfer: invasive PGT-A or after non-invasive PGT-A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryotransfers to conceive | The number of the embryotransfers required for women to conceive | Up to the embryotransfer of the last enrolled patient (Dec 2023) | 
| Time interval to conceive | Time interval required for women to conceive (in months): from day of first embryotransfer to positive hCG test | Up to the pregnancy test after the last embryo transfer of an enrolled patient (Jan 2024) | 
| Cumulative Live Birth Rate | Cumulative Live Birth Rate achieved after one OPU treatment | Up to 38 weeks after the embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abortion rate | The spontaneous miscarriage of women in both groups | Up to 2nd trimester miscarriages | 
| DaC rate | The rate of the dilation and curretage rate in both groups | during pregnancy according to Greek Law | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, PGT-A, NON- INVASIVE PGT-A, TIME LAPSE, EMBRYO SELECTION