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

Infertility Clinical Trial

— PrISICE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03371745
• Other study ID #: PrISICE
• Status: Terminated
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California San Francisco	San Francisco	California

Sponsors (8)

Lead Sponsor	Collaborator
Yale University	Augusta University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of California, San Francisco, University of North Carolina, University of Oklahoma, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Related Info