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Next Generation Sequencing Screening for Embryonic Ploidy Status

NCT02032264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2017-03-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Comprehensive Chromosome Screening

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

Morphologically Best

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

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • Reproductive Medicine Associates of New Jersey

    lead OTHER

Principal Investigators

  • Richard T Scott, M.D., HCLD · Reproductive Medicine Associates of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02032264 on ClinicalTrials.gov