Aneuploid OocytesESTEEMNCT01532284
The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis
A study testing Polar Body Biopsy in people with Aneuploid Oocytes, run by European Society of Human Reproduction and Embryology at 8 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 41 years, women only
- Conditions the study is for
- Aneuploid Oocytes
- What is being tested?
- Polar Body Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Feb 2012to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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);
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- 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
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Germany3 sites
Department of Gynecological Endocrinology and Reproductive Medicine, University of Bonn, Bonn, Germany
Bonn
gyn-medicum Göttingen; Zentrum für Kinderwunsch
Göttingen
UNIVERSITÄTSKLINIKUM Schleswig-Holstein - Sektion für gynäkologische Endokrinologie und Reproduktionsmedizin
Lübeck
Belgium1 site
Centre for Reproductive Medicine BRUSSELSIVF and Centre Medical Genetics, Vrije Universiteit Brussel
Brussels
Greece1 site
Department of Medical Genetics, Athens University/Genesis Athens Clinic, Greece
Athens
Israel1 site
Medical Genetics Institute, Shaare Zedek Medical Center and IVF Unit
Jerusalem
Italy1 site
Department of Reproductive Medicine, S.I.S.Me.R., Reproductive Medicine Unit,
Bologna
About this study
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.
- Conditions
- Aneuploid Oocytes
- Being tested
- Polar Body Biopsy
- Keywords
- aneuploid oocytes, ICSI, IVF, Polar Body Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Polar Body Biopsy |
| No Polar Body Biopsy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 year after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aneuploid OocytesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society of Human Reproduction and Embryology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Sermon, European Society of Human Reproduction and Embryology
- Investigators
- Karen Sermon, Prof. dr., Principal investigator, ESHRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532284
- Sponsor's protocol ID
- ESHRE-ESTEEM
- Acronym
- ESTEEM
- Status last verified
- Jan 2018
- First submitted
- 7 Feb 2012
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 37814912Verpoest 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.
PubMed 30085138
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis
- ClinicalTrials.gov ID
- NCT01532284
- Acronym / sponsor ID
- ESTEEM / ESHRE-ESTEEM
- Conditions
- Aneuploid Oocytes
- Keywords
- aneuploid oocytes, ICSI, IVF, Polar Body Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- European Society of Human Reproduction and EmbryologyUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polar Body Biopsy | Experimental | Other: Polar Body BiopsyPB 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 | No intervention | – |
Who may qualify
- Ages
- 36 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polar Body BiopsyPB 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 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Derived from this study: PubMed 37814912Verdyck 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.
- Derived from this study: PubMed 30085138Verpoest 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Sermon, Prof. dr. principal investigator
ESHRE
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polar Body Biopsy in people with Aneuploid Oocytes, run by European Society of Human Reproduction and Embryology at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Belgium, Greece, Israel, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To improve live birth rates. (time frame: up to 1 year after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01532284, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.