Status:
TERMINATED
The PrISICE Clinical Trial (Pre-Implantation Screening and Investigation on the Cryopreservation of Embryos)
Lead Sponsor:
Yale University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Francisco
Conditions:
Infertility
Eligibility:
FEMALE
18-42 years
Phase:
NA
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 bir...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03371745
Start Date
August 21 2018
End Date
December 31 2019
Last Update
October 3 2022
Active Locations (3)
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1
University of California San Francisco
San Francisco, California, United States, 94115
2
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104