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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact of the Biopsy of 1-2 Cells in a PGD Program for Anueploidy Screening

NCT00454311

Healthy

COMPLETED NA

PGT-A Versus Blastocyst Morphology Selection

NCT03095053

Pregnancy

COMPLETED NA

Efficiency of Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts in In Vitro Fertilization

NCT04758819

Infertility

RECRUITING NA

Blastocyst Euploidy Assessment and Conditioned embryO traNsfer

NCT02353364

Infertility

UNKNOWN PHASE1

Noninvasive Chromosomal Screening for Embryo Selection Trial

NCT04732013

Infertility Aneuploidy

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aneuploid Oocytes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Polar Body Biopsy

Intervention Type 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.

No Polar Body Biopsy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

36 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No