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

Not Applicable

Terminated

• Conditions: Infertility
• Interventions: Procedure: Trophectoderm biopsy; Procedure: Cryopreservation; Procedure: Embryo Transfer

• Registration Number: NCT03371745
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-13
• Study Start: 2018-08-21
• Primary Completion: 2019-10-31
• Study Completion: 2019-12-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGS-FET	Cryopreservation	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.
PGS-FET	Trophectoderm biopsy	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.
PGS-FET	Embryo Transfer	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.
FET	Cryopreservation	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.
Fresh	Embryo Transfer	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.
FET	Embryo Transfer	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.

Primary Outcome Measures

Name	Time	Method
Live Birth	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.

Trial Locations

Locations (3)

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