search
Back to results

Next Generation Sequencing Screening for Embryonic Ploidy Status (nexgen)

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Chromosome Screening
Morphologically Best
Sponsored by
Reproductive Medicine Associates of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Next generation sequencing, Embryonic aneuploidy

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Reproductive Medicine Associates of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Comprehensive Chromosome Screening

No Comprehensive Chromosome Screening

Arm Description

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

The patients in this group will proceed with a single or double embryo transfer of the one or two morphologically best embryos.

Outcomes

Primary Outcome Measures

Impact of next generation sequencing on the embryos produced from IVF on implantation rates
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

Full Information

First Posted
January 7, 2014
Last Updated
March 16, 2017
Sponsor
Reproductive Medicine Associates of New Jersey
Collaborators
Ferring Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT02032264
Brief Title
Next Generation Sequencing Screening for Embryonic Ploidy Status
Acronym
nexgen
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Medicine Associates of New Jersey
Collaborators
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Next generation sequencing, Embryonic aneuploidy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive Chromosome Screening
Arm Type
Experimental
Arm Description
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
Arm Title
No Comprehensive Chromosome Screening
Arm Type
Placebo Comparator
Arm Description
The patients in this group will proceed with a single or double embryo transfer of the one or two morphologically best embryos.
Intervention Type
Other
Intervention Name(s)
Comprehensive Chromosome Screening
Other Intervention Name(s)
PGD, CCS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Morphologically Best
Other Intervention Name(s)
Unscreened, No CCS
Intervention Description
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
Primary Outcome Measure Information:
Title
Impact of next generation sequencing on the embryos produced from IVF on implantation rates
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Delivery Rates
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard T Scott, M.D., HCLD
Organizational Affiliation
Reproductive Medicine Associates of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32898291
Citation
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.
Results Reference
derived
PubMed Identifier
32863013
Citation
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.
Results Reference
derived
Links:
URL
http://www.rmanj.com/
Description
Reproductive Medicine Associates of New Jersey

Learn more about this trial

Next Generation Sequencing Screening for Embryonic Ploidy Status

We'll reach out to this number within 24 hrs