The PrISICE Clinical Trial (Pre-Implantation Screening and Investigation on the Cryopreservation of Embryos)
NCT ID: NCT03371745
Last Updated: 2022-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
32 participants
INTERVENTIONAL
2018-08-21
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Trophectoderm biopsy
Biopsy at blastocyst stage of trophectoderm cells for comprehensive evaluation of the eupolid status of the embryo.
Cryopreservation
Rapid freezing using vitrification
Embryo Transfer
Transfer of embryo that has been cultured in vitro into the uterus
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.
Cryopreservation
Rapid freezing using vitrification
Embryo Transfer
Transfer of embryo that has been cultured in vitro into the uterus
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.
Embryo Transfer
Transfer of embryo that has been cultured in vitro into the uterus
Interventions
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Trophectoderm biopsy
Biopsy at blastocyst stage of trophectoderm cells for comprehensive evaluation of the eupolid status of the embryo.
Cryopreservation
Rapid freezing using vitrification
Embryo Transfer
Transfer of embryo that has been cultured in vitro into the uterus
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
42 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of California, San Francisco
OTHER
University of Pennsylvania
OTHER
Augusta University
OTHER
Penn State University
OTHER
University of North Carolina
OTHER
University of Oklahoma
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Esther Eisenberg, MD
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver National Institue of Child Health and Human Development
Nanette Santoro, MD
Role: STUDY_CHAIR
University of Colorado, Denver
Marcelle I Cedars, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Christos Coutifaris, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Heping Zhang, PhD
Role: STUDY_DIRECTOR
Yale University
Locations
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University of California San Francisco
San Francisco, California, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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PrISICE
Identifier Type: -
Identifier Source: org_study_id
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