NCT01532284

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 14, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

4.8 years

First QC Date

February 7, 2012

Last Update Submit

January 12, 2018

Conditions

Aneuploid Oocytes

Keywords

aneuploid oocytesICSIIVFPolar Body Biopsy

Outcome Measures

Primary Outcomes (2)

  • 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.

    up to 1 year after birth

  • 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.

    Up to 1 year after birth

Study Arms (2)

Polar Body Biopsy

EXPERIMENTAL

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

No Polar Body Biopsy

NO INTERVENTION

Interventions

Polar Body BiopsyOTHER

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.

Polar Body Biopsy

Eligibility Criteria

Age36 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Centre for Reproductive Medicine BRUSSELSIVF and Centre Medical Genetics, Vrije Universiteit Brussel

Brussels, Belgium

Location

Department of Gynecological Endocrinology and Reproductive Medicine, University of Bonn, Bonn, Germany

Bonn, Germany

Location

gyn-medicum Göttingen; Zentrum für Kinderwunsch

Göttingen, Germany

Location

UNIVERSITÄTSKLINIKUM Schleswig-Holstein - Sektion für gynäkologische Endokrinologie und Reproduktionsmedizin

Lübeck, Germany

Location

Department of Medical Genetics, Athens University/Genesis Athens Clinic, Greece

Athens, Greece

Location

Medical Genetics Institute, Shaare Zedek Medical Center and IVF Unit

Jerusalem, Israel

Location

Department of Reproductive Medicine, S.I.S.Me.R., Reproductive Medicine Unit,

Bologna, Italy

Location

Institut Universitari Dexeus

Barcelona, Catalonia, Spain

Location

Related Publications (2)

  • Verdyck P, Altarescu G, Santos-Ribeiro S, Vrettou C, Koehler U, Griesinger G, Goossens V, Magli C, Albanese C, Parriego M, Coll L, Ron-El R, Sermon K, Traeger-Synodinos J. Aneuploidy in oocytes from women of advanced maternal age: analysis of the causal meiotic errors and impact on embryo development. Hum Reprod. 2023 Dec 4;38(12):2526-2535. doi: 10.1093/humrep/dead201.

    PMID: 37814912DERIVED

  • 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.

    PMID: 30085138DERIVED

Study Officials

  • Karen Sermon, Prof. dr.

    ESHRE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 14, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2016

Study Completion

September 1, 2017

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

IT(1)ES(1)BE(1)IL(1)DE(3)GR(1)