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

Primary Purpose

Aneuploid Oocytes

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Polar Body Biopsy
Sponsored by
European Society of Human Reproduction and Embryology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Aneuploid Oocytes focused on measuring aneuploid oocytes, ICSI, IVF, Polar Body Biopsy

Eligibility Criteria

36 Years - 41 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Polar Body Biopsy

No Polar Body Biopsy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 7, 2012
Last Updated
January 12, 2018
Sponsor
European Society of Human Reproduction and Embryology
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1. Study Identification

Unique Protocol Identification Number
NCT01532284
Brief Title
The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis
Acronym
ESTEEM
Official Title
The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European Society of Human Reproduction and Embryology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneuploid Oocytes
Keywords
aneuploid oocytes, ICSI, IVF, Polar Body Biopsy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
396 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polar Body Biopsy
Arm Type
Experimental
Arm Description
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.
Arm Title
No Polar Body Biopsy
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Polar Body Biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
To improve live birth rates.
Description
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.
Time Frame
up to 1 year after birth
Title
To assess the prediction value of having no euploid oocytes in future ART cycles.
Description
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.
Time Frame
Up to 1 year after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Sermon, Prof. dr.
Organizational Affiliation
ESHRE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Reproductive Medicine BRUSSELSIVF and Centre Medical Genetics, Vrije Universiteit Brussel
City
Brussels
Country
Belgium
Facility Name
Department of Gynecological Endocrinology and Reproductive Medicine, University of Bonn, Bonn, Germany
City
Bonn
Country
Germany
Facility Name
gyn-medicum Göttingen; Zentrum für Kinderwunsch
City
Göttingen
Country
Germany
Facility Name
UNIVERSITÄTSKLINIKUM Schleswig-Holstein - Sektion für gynäkologische Endokrinologie und Reproduktionsmedizin
City
Lübeck
Country
Germany
Facility Name
Department of Medical Genetics, Athens University/Genesis Athens Clinic, Greece
City
Athens
Country
Greece
Facility Name
Medical Genetics Institute, Shaare Zedek Medical Center and IVF Unit
City
Jerusalem
Country
Israel
Facility Name
Department of Reproductive Medicine, S.I.S.Me.R., Reproductive Medicine Unit,
City
Bologna
Country
Italy
Facility Name
Institut Universitari Dexeus
City
Barcelona
State/Province
Catalonia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30085138
Citation
Verpoest W, Staessen C, Bossuyt PM, Goossens V, Altarescu G, Bonduelle M, Devesa M, Eldar-Geva T, Gianaroli L, Griesinger G, Kakourou G, Kokkali G, Liebenthron J, Magli MC, Parriego M, Schmutzler AG, Tobler M, van der Ven K, Geraedts J, Sermon K. Preimplantation genetic testing for aneuploidy by microarray analysis of polar bodies in advanced maternal age: a randomized clinical trial. Hum Reprod. 2018 Sep 1;33(9):1767-1776. doi: 10.1093/humrep/dey262.
Results Reference
derived

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

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