TerminatedNot Applicable

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

Stopped: The Reproductive Medicine Network was disbanded

United States32 participantsStarted 2018-08-21

Plain-language 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.

Who can participate

Age range

18 Years – 42 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Live Birth

Timeframe: up to 9 months or time of birth

Trial details

NCT IDNCT03371745

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-31

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