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The PrISICE Clinical Trial (Pre-Implantation Screening and Investigation on the Cryopreservation of Embryos) (PrISICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371745
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : January 6, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Francisco
University of Pennsylvania
Augusta University
Penn State University
University of North Carolina
University of Oklahoma
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE December 8, 2017
First Posted Date  ICMJE December 13, 2017
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE August 21, 2018
Actual Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
Live Birth [ Time Frame: up to 9 months or time of birth ]
The number of subjects who deliver a live born infant which will be calculated into a live born delivery rate.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PrISICE Clinical Trial (Pre-Implantation Screening and Investigation on the Cryopreservation of Embryos)
Official Title  ICMJE A Prospective, Randomized, Controlled Clinical Trial Evaluating the Superiority of Preimplantation Genetic Screening (PGS) and Deferred Transfer of Cryopreserved Embryos Over "Freeze-Only" Deferred Transfer Without PGS or Immediate Embryo Transfer During a "Fresh" In Vitro Fertilization Cycle
Brief Summary The trial objective is to determine whether the deferred transfer of embryos following cryopreservation at the blastocyst stage following pre-implantation genetic screening (PGS-FET) improves live birthrates compared to both the deferred transfer of cryopreserved embryos without PGS (FET) and immediate transfer at the conclusion of a "fresh" in vitro fertilization (IVF) cycle (Fresh). Additionally, whether "freeze-only" (FET) improves live birth rates compared to "fresh" will be determined.
Detailed Description

This will be a multi-center, prospective randomized clinical trial comparing three standards of care:

Group 1: PGS-FET group: deferred transfer of day 5/6/7 (blastocyst stage) embryos cryopreserved following trophectoderm biopsy Group 2: "freeze-only" (FET) group: deferred transfer of frozen/thawed embryos without biopsy Group 3: "fresh" ET group: immediate transfer of "fresh" embryos in the stimulation cycle.

1539 eligible couples will be recruited to participate. Couples will be randomized at retrieval to undergo cryopreservation with deferred embryo transfer, with or without PGS, or fresh embryo transfer during the cycle of egg retrieval. Number of embryos to transfer will be based on clinical estimation of embryo quality and will not exceed ASRM guidelines for embryo transfer number including newly revised guidelines. We are aware that the number of embryos transferred, to maintain enrollment, may not be equivalent, with likely more embryos transferred in patients not having PGS. The primary outcome of live birth/retrieval, with a secondary outcome of healthy singleton birth, may reflect the true benefit of PGS.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Procedure: Trophectoderm biopsy
    Biopsy at blastocyst stage of trophectoderm cells for comprehensive evaluation of the eupolid status of the embryo.
  • Procedure: Cryopreservation
    Rapid freezing using vitrification
  • Procedure: Embryo Transfer
    Transfer of embryo that has been cultured in vitro into the uterus
Study Arms  ICMJE
  • Active Comparator: PGS-FET
    The PGS-FET arm involves deferred transfer of embryos following cryopreservation at the blastocyst stage following pre-implantation genetic screening. This arm will culture embryos to day 5/6/7 (blastocyst stage). The embryos will be cryopreserved following trophectoderm biopsy. A subsequent frozen embryo transfer cycle will be performed during which 1 euploid (chromosomally normal) embryo will be thawed and transferred.
    Interventions:
    • Procedure: Trophectoderm biopsy
    • Procedure: Cryopreservation
    • Procedure: Embryo Transfer
  • Active Comparator: FET
    The "Freeze only" arm involves the deferred transfer of embryos following cryopreservation. In this arm embryos will be cryopreserved. A subsequent frozen embryo transfer cycle will be performed during which one or more embryos will be thawed and transfered based on local clinical site, age-specific embryo number transfer guidelines.
    Interventions:
    • Procedure: Cryopreservation
    • Procedure: Embryo Transfer
  • Active Comparator: Fresh
    The Fresh arm will have an immediate embryo(s) transfer based on local clinical site, age-specific embryo number transfer guidelines within the stimulation cycle.
    Intervention: Procedure: Embryo Transfer
Publications * 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:CD005291. doi: 10.1002/14651858.CD005291.pub3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2019)
32
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
1539
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Scheduled to undergo in vitro fertilization for treatment of infertility (1st or 2nd "fresh" attempt); subject can have had no more than one prior failed "fresh" IVF cycle
  • Couple able to participate in a research project

    • Able to understand study requirements
    • Willing to sign informed consent
    • Able to return for required follow-up
    • Access to telephone
    • Ability to read and write
  • Normal uterine cavity evaluation within one year of enrollment

Exclusion Criteria:

  • Medical conditions which may complicate treatment
  • No plans to undergo embryo transfer
  • Medical contraindication to the transfer of more than a single embryo (i.e. congenital uterine anomaly).
  • Concurrent participation in any other interventional trial
  • Recurrent pregnancy loss
  • Known chromosomal abnormality (e.g. translocation)
  • Pre-implantation genetic diagnosis requiring blastocyst biopsy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03371745
Other Study ID Numbers  ICMJE PrISICE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD data will be deposited in DASH following publication of the results of the primary paper and when the deidentified data have been put into a format that is acceptable for DASH submission.
Time Frame: After publication of the results of the primary paper and when the de-identified data have been put into a format that is acceptable for DASH submission.
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of California, San Francisco
  • University of Pennsylvania
  • Augusta University
  • Penn State University
  • University of North Carolina
  • University of Oklahoma
Investigators  ICMJE
Study Director: Esther Eisenberg, MD Eunice Kennedy Shriver National Institue of Child Health and Human Development
Study Chair: Nanette Santoro, MD University of Colorado, Denver
Principal Investigator: Marcelle I Cedars, MD University of California, San Francisco
Principal Investigator: Christos Coutifaris, MD PhD University of Pennsylvania
Study Director: Heping Zhang, PhD Yale University
PRS Account Yale University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP