The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis

Aneuploid Oocytes Clinical Trial

— ESTEEM  

Official title:

The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532284
• Other study ID #: ESHRE-ESTEEM
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: January 12, 2018
• Start date: February 2012
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: European Society of Human Reproduction and Embryology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: September 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 36 Years to 41 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneuploid Oocytes
• Aneuploidy

Intervention

Other:
• Polar Body Biopsy
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.

Locations

Country	Name	City	State
Belgium	Centre for Reproductive Medicine BRUSSELSIVF and Centre Medical Genetics, Vrije Universiteit Brussel	Brussels
Germany	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
Greece	Department of Medical Genetics, Athens University/Genesis Athens Clinic, Greece	Athens
Israel	Medical Genetics Institute, Shaare Zedek Medical Center and IVF Unit	Jerusalem
Italy	Department of Reproductive Medicine, S.I.S.Me.R., Reproductive Medicine Unit,	Bologna
Spain	Institut Universitari Dexeus	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Human Reproduction and Embryology

Countries where clinical trial is conducted

Belgium,  Germany,  Greece,  Israel,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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