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

NCT03371745 | Terminated DMC

• 1 other identifier: PrISICE
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Live Birth

  The number of subjects who deliver a live born infant which will be calculated into a live born delivery rate.

  up to 9 months or time of birth

Study Arms (3)

PGS-FET

ACTIVE COMPARATOR

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; Procedure: Cryopreservation; Procedure: Embryo Transfer

FET

ACTIVE COMPARATOR

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; Procedure: Embryo Transfer

Fresh

ACTIVE COMPARATOR

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

Interventions

Trophectoderm biopsy PROCEDURE

Biopsy at blastocyst stage of trophectoderm cells for comprehensive evaluation of the eupolid status of the embryo.

PGS-FET

Cryopreservation PROCEDURE

Rapid freezing using vitrification

FET; PGS-FET

Embryo Transfer PROCEDURE

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

FET; Fresh; PGS-FET

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of California, San Francisco: collaborator
• University of Pennsylvania: collaborator
• Augusta University: collaborator
• Penn State University: collaborator
• University of North Carolina: collaborator
• University of Oklahoma: collaborator

Study Sites (3)

University of California San Francisco

San Francisco, California, 94115, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 32898291 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Interventions

Cryopreservation; Embryo Transfer

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques; Reproductive Techniques, Assisted; Reproductive Techniques

Study Officials

• Esther Eisenberg, MD

  Eunice Kennedy Shriver National Institue of Child Health and Human Development

  STUDY DIRECTOR

• Nanette Santoro, MD

  University of Colorado, Denver

  STUDY CHAIR

• Marcelle I Cedars, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Christos Coutifaris, MD PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Heping Zhang, PhD

  Yale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: August 21, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (3)