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A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PGT-A | Experimental | PGT-A and freeze-all (by vitrification) of day 5 and/or day 6 and/or day 7 blastocyst(s) and subsequent transfer of euploid or mosaic (≤80%) blastocysts in FET cycles. Luteal phase supplementation (LPS) will be administered according to the participating clinics standard practice. |
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| Control | No Intervention | Non-PGT-A and fresh blastocyst transfer. In the non-PGT-A group, fresh day 5 single blastocyst transfer and/or FET of day 6 and/or day 7 blastocysts is used. LPS will be administered according to the participating clinics standard practice. All surplus day 5, day 6, or day 7 blastocysts will be vitrified. If there is a risk of OHSS, elective freeze-all will be performed. None of the blastocysts will be PGT-A tested. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PGT-A | Diagnostic Test | PGT-A is a technique that allows for the prediction of embryo ploidy status through analysis of a trophectoderm biopsy conducted prior to embryo transfer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate per first embryo transfer | To assess if PGT-A is superior to standard non-PGT-A treatment regarding the live birth rate per first embryo transfer (ET) (or no ET if only aneuploid embryo(s) in the PGT-A group) per randomized woman. | Approximately 12 months after inclusion of the last patient |
| Cumulative live birth rate after one complete ART treatment | To assess if PGT-A is non-inferior compared to standard treatment regarding the cumulative LBR after one complete ART treatment per randomized woman. | Approximately 18 months after inclusion of the last patient |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anja Bisgaard Pinborg, MD | Contact | +4535454071 | anja.bisgaard.pinborg@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | København Ø | 2100 | Denmark |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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