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

Infertility Clinical Trial

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

Status Terminated

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Infertility

• NCT number: NCT03371745
• Study type: Interventional
• Source: Yale University
• Status: Terminated
• Phase: N/A
• Start date: August 21, 2018
• Completion date: December 31, 2019