Trial record 15 of 160 for:    reproductive medicine associates of new

Next Generation Sequencing Screening for Embryonic Ploidy Status (nexgen)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Reproductive Medicine Associates of New Jersey
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT02032264
First received: January 7, 2014
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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
Infertility
Other: Comprehensive Chromosome Screening

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)

Resource links provided by NLM:


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: December 2014 (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 Double Embryo Transfer (DET) of the 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 Double Embryo Transfer (DET) of the two morphologically best embryos.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT02032264

Contacts
Contact: Christine V Reda, BSN, RN 973-656-2841 clinicalresearchteam@rmanj.com
Contact: Janine M Casciello, BA 973-656-2841 clinicalresearchteam@rmanj.com

Locations
United States, New Jersey
Reproductive Medicine Associates of New Jersey Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Christine V Reda, BSN, RN    973-656-2841    clinicalresearchteam@rmanj.com   
Contact: Janine M Casciello, BA    973-656-2841    clinicalresearchteam@rmanj.com   
Principal Investigator: Richard T Scott, M.D., HCLD         
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Ferring Pharmaceuticals
Investigators
Principal Investigator: Richard T Scott, M.D., HCLD Reproductive Medicine Associates of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT02032264     History of Changes
Other Study ID Numbers: RMA-2013-04
Study First Received: January 7, 2014
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Reproductive Medicine Associates of New Jersey:
Next generation sequencing
Embryonic aneuploidy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 15, 2014