Completed

NCT Number: NCT01532284

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

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.

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Key information

Conditions

Aneuploid Oocytes

Age range

36 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polar Body Biopsy

Other

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 outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

European Society of Human Reproduction and Embryology

Other

Registry information

Acronym: ESTEEM

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2017
First posted: Feb 14, 2012
Registry last updated: Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.