InfertilityPrISICENCT03371745
The PrISICE Clinical Trial (Pre-Implantation Screening and Investigation on the Cryopreservation of Embryos)
A study testing Trophectoderm biopsy, Cryopreservation and Embryo Transfer in people with Infertility, run by Yale University at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Trophectoderm biopsy, Cryopreservation and Embryo Transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Aug 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California San Francisco
San Francisco, California, 94115
About this study
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
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.
Read the 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 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.
- Conditions
- Infertility
- Being tested
- Trophectoderm biopsy, Cryopreservation, Embryo Transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trophectoderm biopsyProcedure or surgery
Biopsy at blastocyst stage of trophectoderm cells for comprehensive evaluation of the eupolid status of the embryo.
CryopreservationProcedure or surgery
Rapid freezing using vitrification
Embryo TransferProcedure or surgery
Transfer of embryo that has been cultured in vitro into the uterus
| Study group | Role | What they receive |
|---|---|---|
| PGS-FET | Active comparator | The PGS-FET arm involves deferred transfer of embryos following cryopreservation at the blastocyst stage following pre-implantation genetic screening. This arm will culture embryos to day 5/6/7 (blastocyst stage). The embryos will be cryopreserved following trophectoderm biopsy. A subsequent frozen embryo transfer cycle will be performed during which 1 euploid (chromosomally normal) embryo will be thawed and transferred. Receives: Procedure: Trophectoderm biopsy; Procedure: Cryopreservation; Procedure: Embryo Transfer |
| FET | Active comparator | The "Freeze only" arm involves the deferred transfer of embryos following cryopreservation. In this arm embryos will be cryopreserved. A subsequent frozen embryo transfer cycle will be performed during which one or more embryos will be thawed and transfered based on local clinical site, age-specific embryo number transfer guidelines. Receives: Procedure: Cryopreservation; Procedure: Embryo Transfer |
| Fresh | Active comparator | The Fresh arm will have an immediate embryo(s) transfer based on local clinical site, age-specific embryo number transfer guidelines within the stimulation cycle. Receives: Procedure: Embryo Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
The number of subjects who deliver a live born infant which will be calculated into a live born delivery rate.
Measured: up to 9 months or time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start21 Aug 2018
- Primary completion31 Oct 2019
- Study completion31 Dec 2019
Why it stopped: The Reproductive Medicine Network was disbanded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Francisco, University of Pennsylvania, Augusta University, Penn State University, University of North Carolina, University of Oklahoma
- Responsible party
- Sponsor
- Investigators
- Esther Eisenberg, MD, Study director, Eunice Kennedy Shriver National Institue of Child Health and Human DevelopmentNanette Santoro, MD, Study chair, University of Colorado, DenverMarcelle I Cedars, MD, Principal investigator, University of California, San FranciscoChristos Coutifaris, MD PhD, Principal investigator, University of PennsylvaniaHeping Zhang, PhD, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371745
- Sponsor's protocol ID
- PrISICE
- Acronym
- PrISICE
- Status last verified
- Sep 2022
- First submitted
- 8 Dec 2017
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD data will be deposited in DASH following publication of the results of the primary paper and when the deidentified data have been put into a format that is acceptable for DASH submission.
Publications
Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
PubMed 32898291
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03371745
- Acronym / sponsor ID
- PrISICE / PrISICE
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Reproductive Medicine Network was disbanded
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Francisco, University of Pennsylvania, Augusta University, Penn State University, University of North Carolina, University of Oklahoma
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PGS-FET | Active comparator | Procedure: Trophectoderm biopsy, Procedure: Cryopreservation, Procedure: Embryo TransferThe PGS-FET arm involves deferred transfer of embryos following cryopreservation at the blastocyst stage following pre-implantation genetic screening. This arm will culture embryos to day 5/6/7 (blastocyst stage). The embryos will be cryopreserved following trophectoderm biopsy. A subsequent frozen embryo transfer cycle will be performed during which 1 euploid (chromosomally normal) embryo will be thawed and transferred. |
| FET | Active comparator | Procedure: Cryopreservation, Procedure: Embryo TransferThe "Freeze only" arm involves the deferred transfer of embryos following cryopreservation. In this arm embryos will be cryopreserved. A subsequent frozen embryo transfer cycle will be performed during which one or more embryos will be thawed and transfered based on local clinical site, age-specific embryo number transfer guidelines. |
| Fresh | Active comparator | Procedure: Embryo TransferThe Fresh arm will have an immediate embryo(s) transfer based on local clinical site, age-specific embryo number transfer guidelines within the stimulation cycle. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
- Normal uterine cavity evaluation within one year of enrollment
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trophectoderm biopsyBiopsy at blastocyst stage of trophectoderm cells for comprehensive evaluation of the eupolid status of the embryo. | Procedure or surgery | PGS-FET |
| CryopreservationRapid freezing using vitrification | Procedure or surgery | FET, PGS-FET |
| Embryo TransferTransfer of embryo that has been cultured in vitro into the uterus | Procedure or surgery | FET, Fresh, PGS-FET |
Primary outcome
Live Birth
Time frame: up to 9 months or time of birth
The number of subjects who deliver a live born infant which will be calculated into a live born delivery rate.
Results and safety
The study was stopped early (reason given: The Reproductive Medicine Network was disbanded). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Derived from this study: PubMed 32898291Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD data will be deposited in DASH following publication of the results of the primary paper and when the deidentified data have been put into a format that is acceptable for DASH submission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Eisenberg, MD study director
Eunice Kennedy Shriver National Institue of Child Health and Human Development
Nanette Santoro, MD study chair
University of Colorado, Denver
Marcelle I Cedars, MD principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trophectoderm biopsy, Cryopreservation and Embryo Transfer in people with Infertility, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Reproductive Medicine Network was disbanded). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth (time frame: up to 9 months or time of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.