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A pragmatic, multicentre, randomized double-blind controlled trial with an intention-to-treat analysis, of the use of preimplantation genetic screening (PGS) for aneuploidy by means of microarray comparative genomic hybridization (CGH) for the chromosomal analysis of the polar bodies (PB) of oocytes collected after ovarian stimulation for in vitro fertilization (IVF), and with the intention to assess the genetic competence of oocytes of advanced biological age, and the effect of this technique on reproductive outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polar Body Biopsy | Experimental | PB biopsy (PBB) will be performed between 9 and 12 hours after ICSI using laser or the mechanical procedure. PB1 and PB2 will be removed simultaneously (both at the same time) and transferred to different tubes for the chromosomal analysis. |
|
| No Polar Body Biopsy | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polar Body Biopsy | Other | PB biopsy (PBB) will be performed between 9 and 12 hours after ICSI using laser or the mechanical procedure. PB1 and PB2 will be removed simultaneously (both at the same time) and transferred to different tubes for the chromosomal analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| To improve live birth rates. | This trial has two primary aims among women with advanced maternal age (1) to improve live birth rates and (2) to assess the prediction value of having no euploid oocytes in future ART cycles. | up to 1 year after birth |
| To assess the prediction value of having no euploid oocytes in future ART cycles. | This trial has two primary aims among women with advanced maternal age (1) to improve live birth rates and (2) to assess the prediction value of having no euploid oocytes in future ART cycles. | Up to 1 year after birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Sermon, Prof. dr. | ESHRE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Reproductive Medicine BRUSSELSIVF and Centre Medical Genetics, Vrije Universiteit Brussel | Brussels | Belgium | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37814912 | Derived | Verdyck P, Altarescu G, Santos-Ribeiro S, Vrettou C, Koehler U, Griesinger G, Goossens V, Magli C, Albanese C, Parriego M, Coll L, Ron-El R, Sermon K, Traeger-Synodinos J. Aneuploidy in oocytes from women of advanced maternal age: analysis of the causal meiotic errors and impact on embryo development. Hum Reprod. 2023 Dec 4;38(12):2526-2535. doi: 10.1093/humrep/dead201. | |
| 30085138 |
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| Department of Gynecological Endocrinology and Reproductive Medicine, University of Bonn, Bonn, Germany |
| Bonn |
| Germany |
| gyn-medicum Göttingen; Zentrum für Kinderwunsch | Göttingen | Germany |
| UNIVERSITÄTSKLINIKUM Schleswig-Holstein - Sektion für gynäkologische Endokrinologie und Reproduktionsmedizin | Lübeck | Germany |
| Department of Medical Genetics, Athens University/Genesis Athens Clinic, Greece | Athens | Greece |
| Medical Genetics Institute, Shaare Zedek Medical Center and IVF Unit | Jerusalem | Israel |
| Department of Reproductive Medicine, S.I.S.Me.R., Reproductive Medicine Unit, | Bologna | Italy |
| Institut Universitari Dexeus | Barcelona | Catalonia | Spain |
| Derived |
| Verpoest W, Staessen C, Bossuyt PM, Goossens V, Altarescu G, Bonduelle M, Devesa M, Eldar-Geva T, Gianaroli L, Griesinger G, Kakourou G, Kokkali G, Liebenthron J, Magli MC, Parriego M, Schmutzler AG, Tobler M, van der Ven K, Geraedts J, Sermon K. Preimplantation genetic testing for aneuploidy by microarray analysis of polar bodies in advanced maternal age: a randomized clinical trial. Hum Reprod. 2018 Sep 1;33(9):1767-1776. doi: 10.1093/humrep/dey262. |