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

Yale University32 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertility

Interventions

Trophectoderm biopsyPROCEDURE

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

CryopreservationPROCEDURE

Rapid freezing using vitrification

Embryo TransferPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 42 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Live Birth

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

Time frame: up to 9 months or time of birth

Data from ClinicalTrials.gov

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