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OpenTrials
Completed

NCT Number: NCT02032264

Next Generation Sequencing Screening for Embryonic Ploidy Status

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Chromosome Screening

Other

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

Morphologically Best

Other

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 outcomes

  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 outcomes

  1. Delivery Rates

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Collaborators

  • Ferring Pharmaceuticals

Registry information

Official study title

Evaluation of the Efficacy of Next Generation Sequencing in Predicting Embryonic Karyotype and Subsequent Pregnancy Outcomes in in Vitro Fertilization Cycles (IVF)

Acronym: nexgen

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jan 10, 2014
Registry last updated
Mar 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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