Noninvasive Chromosomal Screening for Embryo Selection Trial
NICEST
Nonselection Pilot Study to Assess the Clinical Efficacy of Noninvasive Preimplantation Genetic Testing for Aneuploidy
1 other identifier
observational
120
1 country
1
Brief Summary
To determine the diagnostic accuracy of non-invasive preimplantation genetic testing for aneuploidy (NI-PGT-A) for embryo selection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2020
CompletedStudy Start
First participant enrolled
December 4, 2020
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2022
CompletedApril 21, 2022
April 1, 2022
1.8 years
November 27, 2020
April 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Predictive value of NI-PGT-A results with implantation rate.
Positive and negative predictive value of NI-PGT-A results to embryo implantation rate determined by quantitative hCG levels and ultrasound findings.
1 year
Predictive value of NI-PGT-A results with on-going pregnancy rate.
Positive and negative predictive values of NI-PGT-A results with ongoing pregnancy rates as determined by viability through the 1st trimester.
1 year
Predictive value of NI-PGT-A results with miscarriage rate.
Positive and negative predictive values of NI-PGT-A results with miscarriage rates documented in the 1st trimester.
1 year
Study Arms (1)
Study cohort
Single observational cohort of patients who meet study criteria
Interventions
Eligibility Criteria
Patients undergoing IVF-ICSI at the Olive Fertility Centre that fit the eligibility criteria.
You may qualify if:
- Patient undergoing IVF-ICSI at the Olive Fertility Centre
- years old at the time of enrolment
- Elective freeze-all cycle
- Planning for single embryo transfer
You may not qualify if:
- Undergoing PGT-A, PGT-SR, PGT-M
- History of recurrent pregnancy loss
- History of recurrent implantation failure
- Planning on transfer of more than 1 embryo
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Olive Fertility Centrelead
- Thermo Fisher Scientific, Inccollaborator
- Sequence46collaborator
Study Sites (1)
Olive Fertility Centre
Vancouver, British Columbia, V6R1L4, Canada
Related Publications (1)
Nakhuda G, Rodriguez S, Tormasi S, Welch C. A pilot study to investigate the clinically predictive values of copy number variations detected by next-generation sequencing of cell-free deoxyribonucleic acid in spent culture media. Fertil Steril. 2024 Jul;122(1):42-51. doi: 10.1016/j.fertnstert.2024.02.030. Epub 2024 Feb 19.
PMID: 38382698DERIVED
Biospecimen
Spent culture media from cultured blastocysts which is typically discarded will be collected to isolate free DNA.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Nakhuda, MD
Olive Fertility Centre
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Director
Study Record Dates
First Submitted
November 27, 2020
First Posted
February 1, 2021
Study Start
December 4, 2020
Primary Completion
September 4, 2022
Study Completion
December 4, 2022
Last Updated
April 21, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share