- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02032264
Next Generation Sequencing Screening for Embryonic Ploidy Status (nexgen)
March 16, 2017 updated by: Reproductive Medicine Associates of New Jersey
Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)
To evaluate the benefits of using next generation sequencing to assess embryonic aneuploidy.
All viable blastocysts will be biopsied and cryopreserved for future transfer.
After the final embryo is cryopreserved, patients will be randomized to either the intervention group or the control group.
Patients and doctors are blinded to the randomization until study completion.
A Double Embryo Transfer (DET) will be performed with either screened or unscreened embryos depending on randomization.
A Single Embryo Transfer (SET) may occur in cases where only one embryo is available for transfer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
309
Phase
- 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
-
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Reproductive Medicine Associates of New Jersey
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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
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patient undergoing IVF/CCS (no PGD banking)
- Patient meets ASRM guidelines for Double Embryo Transfer (DET)
- Donor Sperm OK
- AMH ≥ 1.2
- FSH ≤ 12
- BAFC ≥12
- Max 1 prior failed IVF cycle for patients 35-45 years old
- Patient <35 years old MUST have 1 prior failed IVF cycle
Exclusion Criteria:
- Chronic endometrial insufficiency
- Use of oocyte donor or gestational carriers
- Medical contraindications to Double Embryo Transfer (DET)
- Male Factor (<100,000 sperm or surgical sperm)
- Communicating hydrosalpinx (on HSG)
- Single gene disorders or sex selection
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Comprehensive Chromosome Screening
Trophectoderm biopsy will be performed on all blastocysts and CCS via next generation sequencing screening performed on biopsy samples.
Patients will proceed with a single or double embryo transfer of the one or two morphologically best euploid embryos
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On day 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study.
Comprehensive Chromosome Screening (CCS), will be performed via next generation sequencing and results will be available at the time of study completion.
Other Names:
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Placebo Comparator: No Comprehensive Chromosome Screening
The patients in this group will proceed with a single or double embryo transfer of the one or two morphologically best embryos.
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Patients in this arm of the study will not receive CCS in selection of their embryo for transfer.
The best looking embryo (morphology) will be transferred
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of next generation sequencing on the embryos produced from IVF on implantation rates
Time Frame: 2 years
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To evaluate the benefits, if any, of using next generation sequencing based Comprehensive Chromosome Screening (CCS) in the selection of embryos for transfer during clinical IVF cycles
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Delivery Rates
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Richard T Scott, M.D., HCLD, Reproductive Medicine Associates of New Jersey
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
- Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
- Tiegs AW, Tao X, Zhan Y, Whitehead C, Kim J, Hanson B, Osman E, Kim TJ, Patounakis G, Gutmann J, Castelbaum A, Seli E, Jalas C, Scott RT Jr. A multicenter, prospective, blinded, nonselection study evaluating the predictive value of an aneuploid diagnosis using a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy assay and impact of biopsy. Fertil Steril. 2021 Mar;115(3):627-637. doi: 10.1016/j.fertnstert.2020.07.052. Epub 2020 Aug 28.
Helpful Links
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
December 1, 2013
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
January 7, 2014
First Submitted That Met QC Criteria
January 9, 2014
First Posted (Estimate)
January 10, 2014
Study Record Updates
Last Update Posted (Actual)
March 17, 2017
Last Update Submitted That Met QC Criteria
March 16, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMA-2013-04
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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