Next Generation Sequencing Screening for Embryonic Ploidy Status (nexgen)

This study is ongoing, but not recruiting participants.
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey Identifier:
First received: January 7, 2014
Last updated: November 16, 2015
Last verified: November 2015
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 Intervention
Other: Comprehensive Chromosome Screening
Other: Morphologically Best

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Further study details as provided by Reproductive Medicine Associates of New Jersey:

Primary Outcome Measures:
  • Impact of next generation sequencing on the embryos produced from IVF on implantation rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Delivery Rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: December 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 42 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02032264

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
Principal Investigator: Richard T Scott, M.D., HCLD Reproductive Medicine Associates of New Jersey
  More Information

Additional Information:
Responsible Party: Reproductive Medicine Associates of New Jersey Identifier: NCT02032264     History of Changes
Other Study ID Numbers: RMA-2013-04 
Study First Received: January 7, 2014
Last Updated: November 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Reproductive Medicine Associates of New Jersey:
Next generation sequencing
Embryonic aneuploidy processed this record on May 26, 2016