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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

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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Trophectoderm biopsy Procedure: Cryopreservation Procedure: Embryo Transfer Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 21, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
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.
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

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.
Procedure: Cryopreservation
Rapid freezing using vitrification

Procedure: Embryo Transfer
Transfer of embryo that has been cultured in vitro into the uterus

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.
Procedure: Embryo Transfer
Transfer of embryo that has been cultured in vitro into the uterus




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371745


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94115
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Yale University
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
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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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03371745    
Other Study ID Numbers: PrISICE
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility