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Next Generation Sequencing Screening for Embryonic Ploidy Status (nexgen)

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ClinicalTrials.gov Identifier: NCT02032264
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : March 17, 2017
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Brief 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.

Condition or disease Intervention/treatment Phase
Infertility Other: Comprehensive Chromosome Screening Other: Morphologically Best Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)
Study Start Date : December 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

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
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 Names:
  • PGD
  • CCS

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.
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
Other Names:
  • Unscreened
  • No CCS

Primary Outcome Measures :
  1. Impact of next generation sequencing on the embryos produced from IVF on implantation rates [ Time Frame: 2 years ]
    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

Secondary Outcome Measures :
  1. Delivery Rates [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032264

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United States, New Jersey
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Ferring Pharmaceuticals
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Principal Investigator: Richard T Scott, M.D., HCLD Reproductive Medicine Associates of New Jersey
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT02032264    
Other Study ID Numbers: RMA-2013-04
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Keywords provided by Reproductive Medicine Associates of New Jersey:
Next generation sequencing
Embryonic aneuploidy
Additional relevant MeSH terms:
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