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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01532284
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Karen Sermon, European Society of Human Reproduction and Embryology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aneuploid Oocytes Other: Polar Body Biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Screening
Official Title: The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis
Study Start Date : February 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. To improve live birth rates. [ Time Frame: up to 1 year after birth ]
    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.

  2. To assess the prediction value of having no euploid oocytes in future ART cycles. [ Time Frame: Up to 1 year after birth ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   36 Years to 41 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532284


Locations
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Belgium
Centre for Reproductive Medicine BRUSSELSIVF and Centre Medical Genetics, Vrije Universiteit Brussel
Brussels, Belgium
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, Germany
Greece
Department of Medical Genetics, Athens University/Genesis Athens Clinic, Greece
Athens, Greece
Israel
Medical Genetics Institute, Shaare Zedek Medical Center and IVF Unit
Jerusalem, Israel
Italy
Department of Reproductive Medicine, S.I.S.Me.R., Reproductive Medicine Unit,
Bologna, Italy
Spain
Institut Universitari Dexeus
Barcelona, Catalonia, Spain
Sponsors and Collaborators
European Society of Human Reproduction and Embryology
Investigators
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Principal Investigator: Karen Sermon, Prof. dr. ESHRE
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Karen Sermon, Prof. dr., European Society of Human Reproduction and Embryology
ClinicalTrials.gov Identifier: NCT01532284    
Other Study ID Numbers: ESHRE-ESTEEM
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Karen Sermon, European Society of Human Reproduction and Embryology:
aneuploid oocytes
ICSI
IVF
Polar Body Biopsy
Additional relevant MeSH terms:
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Aneuploidy
Chromosome Aberrations
Pathologic Processes