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This is a prospective randomised study of the evaluation of the clinical IVF results after time lapse assisted embryo selection versus Non-invasive PGT-A assisted embryo selection in subfertile women.
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 time lapse assisted 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIME LAPSE | Women who proceed to embryo transfer after time lapse assisted embryo selection. |
| |
| NI-PGT-A | Women who proceed to embryo transfer after non-invasive PGT-A assisted embryo selection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| embryo selection | Other | The basis of embryo seletion for transfer: morphological or genetic after non-invasive PGT-A |
|
| 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 OPU day 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 18- 39, faced with infertility issues, meeting the above inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evangelos Papanikolaou, MD,PhD | Contact | 00302310424294 | drvagpapanikolaou@yahoo.gr | |
| Maria Galiotou, MSc | Contact | 00302310424294 | galiotou@assistingnature.gr |
| Name | Affiliation | Role |
|---|---|---|
| Evangelos Papanikolaou, MD,PhD | Assisting Nature | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assisting Nature | Recruiting | Thessaloniki | 57001 | Greece |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D000782 | Aneuploidy |
| D002869 | Chromosome Aberrations |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Up to 24 weeks of pregnancy according to Greek Law |