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DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles

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ClinicalTrials.gov Identifier: NCT03717441
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : February 29, 2024
Sponsor:
Information provided by (Responsible Party):
Mandy Katz-Jaffe, Colorado Center for Reproductive Medicine

Tracking Information
First Submitted Date October 22, 2018
First Posted Date October 24, 2018
Last Update Posted Date February 29, 2024
Actual Study Start Date October 22, 2018
Estimated Primary Completion Date December 15, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2018)		 DNA Analysis of discarded media drops form the clinical IVF Cycles [ Time Frame: 1 day ]
Analyze media drop for presence of DNA to obtain embryo chromosome numeration
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles
Official Title DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles
Brief Summary Performing DNA analysis of discarded media drops from the clinical IVF cycles completed in our Center
Detailed Description The purpose of this research study is to investigate for the presence of DNA in the surrounding media that is remaining after human clinical IVF cycles, to have a non-invasive way of obtaining markers of embryo chromosome numeration. Media recovered from the clinical IVF laboratory is typically discarded during an IVF cycle. Genomic technologies will be used to analyze the otherwise discarded media drop for chromosome counting.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Months
Biospecimen Retention:   Samples With DNA
Description:
Media drops form IVF cycle
Sampling Method Probability Sample
Study Population Recruiting women undergoing In Vitro Fertilization with Comprehensive Chromosomal Screening of embryos
Condition Infertility
Intervention Diagnostic Test: chromosome numeration of embryos
Use genomic technologies to analyze the discarded media drop for chromosome counting
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 22, 2018)		 250
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 15, 2026
Estimated Primary Completion Date December 15, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Any women undergoing an In Vitro Fertilization cycle (IVF) at the Colorado Center for Reproductive Medicine that is also having Comprehensive Chromosomal Screening (CCS) of embryos

Exclusion Criteria:

-
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Rachel Makloski 303-788-8300 ext 1769 rmakloski@colocrm.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03717441
Other Study ID Numbers 2018154
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Mandy Katz-Jaffe, Colorado Center for Reproductive Medicine
Original Responsible Party Same as current
Current Study Sponsor Colorado Center for Reproductive Medicine
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Mandy Katz-Jaffe, PhD Colorado Center for Reproductive Medicine
PRS Account Colorado Center for Reproductive Medicine
Verification Date February 2024