An interventional study of PGT-A in Infertility, sponsored by Copenhagen University Hospital, Rigshospitalet. Recruiting at 1 site in Denmark. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Copenhagen University Hospital, Rigshospitalet · Not applicable, Interventional, and Diagnostic
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.
2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's planned enrollment of 590 is above the median of 120 across 1,722 interventional studies indexed under Infertility.
Browse Infertility studies →Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 35 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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.
Diagnostic Test: PGT-A
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.
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.
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.
Time frame: 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.
Time frame: Approximately 18 months after inclusion of the last patient
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Apr 2028, 44 months after the start.
Of 498 non-industry interventional studies with no phase under Infertility, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 44 months is above that.
Counting every sponsor, half of 541 studies reached it within 23 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Copenhagen University Hospital, Rigshospitalet