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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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 16, 2014
Last verified: June 2014
  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

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

Primary Outcome Measures:
  • To improve live birth rates. [ Time Frame: up to 1 year after birth ] [ Designated as safety issue: No ]
    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.

  • To assess the prediction value of having no euploid oocytes in future ART cycles. [ Time Frame: Up to 1 year after birth ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: February 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: November 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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.         
Czech Republic
Sanatorium REPROMEDA, Center for Reproductive Medicine and Genetics, Laboratory of Clinical and Reproductive Medicine Recruiting
Brno, Czech Republic
Contact: Katerina Veselá         
Principal Investigator: Katerina Veselá, Dr.         
Germany
Department of Gynecological Endocrinology and Reproductive Medicine, University of Bonn, Bonn, Germany Recruiting
Bonn, Germany
Contact: Hans van der Ven, Prof. dr.         
Contact: Katrin van der Ven, Prof. dr.         
Principal Investigator: Hans van der Ven, Prof. dr.         
Sub-Investigator: Katrin van der Ven, 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 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 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 16, 2014
Health Authority: Belgium: Ethics Committee
Germany: Ethics Commission
Italy: Ethics Committee
Israel: Ethics Commission
Czech Republic: Ethics Committee
Greece: Ethics Committee
Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on October 23, 2014