The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis (ESTEEM)

This study is currently recruiting participants.
Verified June 2012 by European Society of Human Reproduction and Embryology
Sponsor:
Information provided by (Responsible Party):
European Society of Human Reproduction and Embryology
ClinicalTrials.gov Identifier:
NCT01532284
First received: February 7, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Aneuploid Oocytes
Other: Polar Body Biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Screening
Official Title: The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis

Resource links provided by NLM:


Further study details as provided by European Society of Human Reproduction and Embryology:

Primary Outcome Measures:
  • The likelihood of having no euploid oocytes in future ART cycles [ Time Frame: up to 1 year after birth ] [ Designated as safety issue: No ]
    The ESTEEM RCT has two primary aims among women with advanced maternal age (1) to estimate the likelihood of having no euploid oocytes in future ART cycles; and (2) to improve live birth rates.

  • Live birth rates [ Time Frame: Up to 1 year after birth ] [ Designated as safety issue: No ]
    The ESTEEM RCT has two primary aims among women with advanced maternal age (1) to estimate the likelihood of having no euploid oocytes in future ART cycles; and (2) to improve live birth rates.


Estimated Enrollment: 600
Study Start Date: February 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
No Intervention: No Polar Body Biopsy

  Eligibility

Ages Eligible for Study:   36 Years to 41 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infertility as an indication for IVF or ICSI; patients between their 36th and 41st birthdays
  • BMI range 20 to 30 kgs per m2, patients prepared to accept transfer of two embryos
  • absence of any type of genetic abnormality in the patient's personal and family history, ICSI is compulsory even with an IVF indication

Exclusion Criteria:

  • cycles involving donor gametes, menstrual irregularity (<24 and >35 days), two or more previous failed IVF or ICSI cycles, poor response in any previous cycle
  • low ovarian reserve (At least two of the following three features must be present:

    1. advanced maternal age (≥ 40 yrs) or any other risk factor for POR
    2. a previous poor ovarian response (≤ 3 oocytes with a conventional stimulation protocol)
    3. an abnormal ovarian reserve test (i.e. AFC < 5-7 follicles or AMH < 0.5-1.1 ng/mL*) (Ferraretti et al., 2011) and cycles requiring surgical sperm recovery procedures, total astenozoospermia and/or globozoospermia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532284

Contacts
Contact: Joep Geraedts, Prof. dr. joep.geraedts@mumc.nl

Locations
Belgium
Centre for Reproductive Medicine BRUSSELSIVF and Centre Medical Genetics, Vrije Universiteit Brussel Recruiting
Brussels, Belgium
Contact: Willem Verpoest, Dr.         
Principal Investigator: Willem Verpoest, Dr.         
Germany
Department of Gynecological Endocrinology and Reproductive Medicine, University of Bonn, Bonn, Germany and Department of Gynaecological Endocrinology and Fertility Disorders, University of Heidelberg Recruiting
Bonn, Germany
Contact: Markus Montag, Prof. dr.         
Principal Investigator: Markus Montag, Prof. dr.         
Centre for Reproductive Medicine, University Women's Hospital, Christian-Albrechts-University Kiel Not yet recruiting
Kiel, Germany
Contact: Andreas Schmutzler, Dr.         
Principal Investigator: Andreas Schumtzler, Dr.         
Greece
Department of Medical Genetics, Athens University/Genesis Athens Clinic, Greece Not yet recruiting
Athens, Greece
Contact: Jan Traeger, Dr.         
Principal Investigator: Jan Traeger, Dr.         
Israel
Medical Genetics Institute, Shaare Zedek Medical Center and IVF Unit Recruiting
Jerusalem, Israel
Contact: Gheona Altarescu, Dr.         
Principal Investigator: Gheona Altarescu, Dr.         
Italy
Department of Reproductive Medicine, S.I.S.Me.R., Reproductive Medicine Unit, Recruiting
Bologna, Italy
Contact: Christian Magli, Dr.         
Principal Investigator: Christina Magli, Dr.         
Spain
Institut Universitari Dexeus Not yet recruiting
Barcelona, Catalonia, Spain
Contact: Monica Parriego Beltran, Dr.         
Principal Investigator: Monica Parriego Beltran, Dr.         
Sponsors and Collaborators
European Society of Human Reproduction and Embryology
Investigators
Principal Investigator: Joep Geraedts, Prof. dr. ESHRE
  More Information

No publications provided

Responsible Party: European Society of Human Reproduction and Embryology
ClinicalTrials.gov Identifier: NCT01532284     History of Changes
Other Study ID Numbers: ESHRE-ESTEEM
Study First Received: February 7, 2012
Last Updated: June 28, 2012
Health Authority: Belgium: Ethics Committee
Germany: Ethics Commission
Italy: Ethics Committee
Israel: Ethics Commission
Greece: Ethics Committee
Spain: Ethics Committee

Keywords provided by European Society of Human Reproduction and Embryology:
aneuploid oocytes
ICSI
IVF
Polar Body Biopsy

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014