ESTEEM will be the first randomised trial of 23 chromosome testing of polar bodies using array CGH. The pilot study showed that reliable identification of the chromosomal status of an oocyte is possible in about 90% of polar body biopsy attempts. The study, now known as ESTEEM (the ESHRE Study into The Evaluation of oocyte Euploidy by Microarray analysis), which will be performed in women aged between 36 and 41 years, has two primary aims: to estimate the likelihood of having no euploid embryos in future ART cycles and to improve live birth rates in women of advanced maternal age.
At the Executive Committee meeting in September 2007 it was agreed that an answer on the question of the value of PGS was extremely important and that further studies were needed to analyse the value of PGS. EHRE would promote these studies if a much needed proposal to conduct an optimal study was developed. This resulted in the formation of the PGS Task Force.
Coordinator of this Task Fore is Prof. Joep Geraedts. Members include John Collins, Paul Devroey, Luca Gianoroli, Alan Handyside, Joyce Harper, Marcus Montag, Sjoerd Repping, Andreas Schmutzler and Katerina Vesela.
The PGS Task Force agreed to carry out a pilot study of PGS - analysing one of each pair of 23 chromosomes in polar bodies - in collaboration with BlueGnome, a DNA technology company based in Cambridge, UK. If the pilot study shows that the technique is feasible, the project will be extended to an international randomised trial, ESHRE’s first sponsored study since 1994.
The first phase began in September 2009 in two centres: the University of Bonn, Germany (with Dr. Markus Montag and Prof. Hans van der Ven) and SISMER, Bologna, Italy (with Drs. Luca Gianaroli and Cristina Magli). The two centres chosen for the pilot study have considerable experience in the field of polar body biopsy. The data from the study will be independently analysed by Dr. Sjoerd Repping, from the Academic Medical Centre in Amsterdam.
Following completion of its pilot study of polar body array CGH for preimplantation genetic screening, the Task Force will be disbanded and its responsibilities passed on to the PGS trial study group. This is in line with ESHRE policy that Task Forces should be temporary groups dealing with specific questions. The PGS Task Force was set up after the annual meeting in Lyon in 2007, where it became clear that cleavage stage biopsy and FISH were not reasonable approaches to PGS. It was then that the idea of a proofof-principle study developed. The positive outcome of that study is now behind the design of a randomised clinical trial in women with advanced maternal age. The trial has two aims: first, to assess the impact of 24-chromosome polar body PGS on live birth rates; and second to estimate whether consistent oocyteaneuploidy in one cycle is predictive of consistent aneuploidy in future cycles.All the prerequisites for a successful trial are now in place - a sponsor (the Cambridge-based company BlueGnome, a specialist developer of microarray-based screening technologies), the study and training centres, and ESHRE’s data management. Following the move of Markus Montag, one of the pilot study co-ordinators, from Bonn to the University of Heidelberg, both siteswill now operate as a joint training and trial centre.
Polar body array CGH for prediction of the status of the corresponding oocyte. Part I: clinical results
Polar body array CGH for prediction of the status of the corresponding oocyte. Part II: technical aspects
Joep GeraedtsEmail: email@example.com
Veerle GoossensEmail: firstname.lastname@example.org
John Collins Email: email@example.com