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

January 12, 2018 updated by: Karen Sermon, European Society of Human Reproduction and Embryology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Centre for Reproductive Medicine BRUSSELSIVF and Centre Medical Genetics, Vrije Universiteit Brussel
  • Germany
      • Bonn, Germany
        • Department of Gynecological Endocrinology and Reproductive Medicine, University of Bonn, Bonn, Germany
      • Göttingen, Germany
        • gyn-medicum Göttingen; Zentrum für Kinderwunsch
      • Lübeck, Germany
        • UNIVERSITÄTSKLINIKUM Schleswig-Holstein - Sektion für gynäkologische Endokrinologie und Reproduktionsmedizin
  • Greece
      • Athens, Greece
        • Department of Medical Genetics, Athens University/Genesis Athens Clinic, Greece
  • Israel
      • Jerusalem, Israel
        • Medical Genetics Institute, Shaare Zedek Medical Center and IVF Unit
  • Italy
      • Bologna, Italy
        • Department of Reproductive Medicine, S.I.S.Me.R., Reproductive Medicine Unit,
  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Institut Universitari Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 1 year after birth
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.
Up to 1 year after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society of Human Reproduction and Embryology

Investigators

  • Principal Investigator: Karen Sermon, Prof. dr., ESHRE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 7, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 14, 2012

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESHRE-ESTEEM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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