Clinical trial NCT01532284: The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis
Official title: The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneuploid Oocytes
Keywords: aneuploid oocytes
ICSI
IVF
Polar Body Biopsy
Lead sponsor: European Society of Human Reproduction and Embryology
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 396
Sex: FEMALE
Minimum age (years): 36
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* infertility as an indication for IVF or ICSI;
* patients between their 36th and 41st birthdays (at time of signing ICF i.e. max 40years and 364days at the day of signing the informed consent);
* BMI range 18 to 30 kgs per m2;
* patients prepared to accept transfer of up to two embryos;
* absence of any type of genetic abnormality in the patient's personal and family history;
* normal karyotype (optional)

Exclusion Criteria:

* treatment involving donor oocytes (donor sperm is allowed subject to local practice and regulations and provided karyotype of the sperm donor is available and normal);
* menstrual irregularity (\<24 and \>35 days);
* three or more previous failed IVF or ICSI cycles, with the present partner. (Definition of a failed cycle: 'absence of a clinical pregnancy relating to a treatment with embryo transfer resulting from oocyte retrieval for the current intended pregnancy and with the current partner; the transfers include transfers of fresh and frozen within this treatment; clinical pregnancy is defined as the presence of a gestational sac at the earliest ultrasound and includes early clinical miscarriage, late miscarriage and clinically confirmed extrauterine pregnancy, and excludes preclinical miscarriage (biochemical pregnancy); -
* three or more clinical miscarriages;
* poor response in any previous cycle;
* low ovarian reserve (At least one of the following two features must be present: (1) a previous poor ovarian response (≤ 3 oocytes with a conventional stimulation 119 protocol); (2) an abnormal ovarian reserve test (i.e. AFC \< 5 follicles or AMH \< 0,5 ng/mL)\* (adapted from Ferraretti et al., 2011);
* cycles requiring surgical sperm recovery procedures;
* total asthenozoospermia and/or globozoospermia.
* any type of genetic abnormality or family history of genetic abnormality in subject or partner

Primary outcomes:
measure: To improve live birth rates.
timeFrame: up to 1 year after birth
measure: To assess the prediction value of having no euploid oocytes in future ART cycles.
timeFrame: Up to 1 year after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre for Reproductive Medicine BRUSSELSIVF and Centre Medical Genetics, Vrije Universiteit Brussel
city: Bonn
country: Germany
facility: Department of Gynecological Endocrinology and Reproductive Medicine, University of Bonn, Bonn, Germany
city: Göttingen
country: Germany
facility: gyn-medicum Göttingen; Zentrum für Kinderwunsch
city: Lübeck
country: Germany
facility: UNIVERSITÄTSKLINIKUM Schleswig-Holstein - Sektion für gynäkologische Endokrinologie und Reproduktionsmedizin
city: Athens
country: Greece
facility: Department of Medical Genetics, Athens University/Genesis Athens Clinic, Greece
city: Jerusalem
country: Israel
facility: Medical Genetics Institute, Shaare Zedek Medical Center and IVF Unit
city: Bologna
country: Italy
facility: Department of Reproductive Medicine, S.I.S.Me.R., Reproductive Medicine Unit,
city: Barcelona
country: Spain
facility: Institut Universitari Dexeus
state: Catalonia
Study officials:
affiliation: ESHRE
name: Karen Sermon, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.