Single Embryo TrAnsfeR of Euploid Embryo (STAR)

May 1, 2020 updated by: Illumina, Inc.

Prospective, Multi-center, Randomized Controlled Trial Comparing Pregnancy Outcomes Following Selection and Single Embryo Transfer (SET) Based on Preimplantation Genetic Screening (PGS) by Next Generation Sequencing (NGS) Versus Standard Morphological Assessment

The purpose of the current study is to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All embryos will be vitrified and a single embryo transfer (SET) will be performed with either screened or unscreened embryos depending on randomization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
661

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Melbourne IVF
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3X7
        • Olive Fertility Centre
    • Ontario
      • Mississauga, Ontario, Canada, L5N 5S3
        • Reproductive Care Center
      • Toronto, Ontario, Canada, M5G 2K4
        • TRIO Fertility Treatment Practice
  • United Kingdom
      • London, United Kingdom
        • Genesis Genetics (UK) - Genetics Laboratory
      • Oxford, United Kingdom
        • Reprogenetics (UK) - Genetics Laboratory
    • Greater London
      • London, Greater London, United Kingdom, NW1 6ER
        • Boston Place Clinic
      • London, Greater London, United Kingdom, NW8 7JL
        • Care Fertility Group London
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M14 SHQ
        • Care Fertility Group Manchester
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX42HW
        • Oxford Fertility Unit
  • United States
    • Arizona
      • Tempe, Arizona, United States, 85284
        • Fertility Treatment Center
    • California
      • Encino, California, United States, 91436
        • HRC Fertility
      • Laguna Niguel, California, United States, 92677
        • Acacio Fertility Clinic
      • Pasadena, California, United States, 91105
        • HRC Fertility Pasadena
      • San Diego, California, United States, 92123
        • Fertility Specialists Medical Group
      • San Ramon, California, United States, 94583
        • Reproductive Science Center of San Francisco Bay Area
    • Colorado
      • Lonetree, Colorado, United States, 80125
        • Colorado Center for Reproductive Medicine (CCRM)
    • Delaware
      • Newark, Delaware, United States, 19713
        • Reproductive Associates of Delaware
    • Florida
      • Orlando, Florida, United States, 32804
        • CRM Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Georgia Reproductive Specialists
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Fertility Institute of Hawaii
    • Illinois
      • Highland Park, Illinois, United States, 60035
        • Fertility Center of Illinois, Highland Park
      • Naperville, Illinois, United States, 60540
        • The Advanced IVF Institute
    • Massachusetts
      • Lexington, Massachusetts, United States, 02421
        • IVF New England
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48304
        • IVF Michigan
      • Plymouth, Michigan, United States
        • Genesis Genetics (USA) - Genetics Laboratory
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Reproductive Science Center of New Jersey
      • Livingston, New Jersey, United States, 07039
        • Reprogenetics (USA) - Genetics Laboratory
      • Livingston, New Jersey, United States, 07078
        • IRMS at St. Barnabas
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Main Line Fertility
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Fertility Center
      • Dallas, Texas, United States, 75231
        • Dallas Fertility Center
      • Frisco, Texas, United States, 75034
        • Dallas IVF
      • Houston, Texas, United States, 77063
        • Houston Fertility Institute
      • Webster, Texas, United States, 77598
        • CORM Houston
    • Utah
      • Pleasant Grove, Utah, United States, 84062
        • Utah Fertility Center
      • Sandy, Utah, United States, 84092
        • Reproductive Care Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Reproductive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient undergoing IVF
  • At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development

Exclusion Criteria:

  • History of more than two prior implantation failure following IVF
  • History of more than one miscarriage of viable pregnancy
  • One or both partners known to be carrier(s) of a chromosomal abnormality
  • Known genetic carrier couple and/or one or both partners carrier of a known autosomal dominant disorder
  • Any other non-study related preimplantation genetic testing
  • Use of donor oocytes
  • Use of gestational carrier (surrogate or donor egg recipient).
  • Severe oligospermia (<1,000,000 sperm/ml); Surgical Sperm Retrieval for reasons other than post-vasectomy and CAVD
  • Low ovarian reserve with (FSH) >10 IU/L on day 2-4 of a prior menstrual cycle and/or (AMH) <7 pmol/L (or <1 ng/ml)
  • Gender selection cycles
  • Concurrent participation in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts
Other: Preimplantation Genetic Screening by NGS
The VeriSeq PGS takes advantage of next-generation sequencing (NGS) technology to provide comprehensive, accurate screening of all 24 chromosomes for selection of euploid embryos.
Other Names:
  • Veriseq PGS
No Intervention: Group B
Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ongoing Pregnancy
Time Frame: Gestational Age of 20 Weeks
Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
Gestational Age of 20 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Illumina, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Reprogenetics
Genesis Genetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RGH-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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