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DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717441
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mandy Katz-Jaffe, Colorado Center for Reproductive Medicine

Brief Summary:
Performing DNA analysis of discarded media drops from the clinical IVF cycles completed in our Center

Condition or disease Intervention/treatment
Infertility Diagnostic Test: chromosome numeration of embryos

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : June 15, 2021

Intervention Details:
  • Diagnostic Test: chromosome numeration of embryos
    Use genomic technologies to analyze the discarded media drop for chromosome counting


Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Media drops form IVF cycle


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Recruiting women undergoing In Vitro Fertilization with Comprehensive Chromosomal Screening of embryos
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717441


Contacts
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Contact: Rachel Makloski 303-788-8300 ext 1769 rmakloski@colocrm.com

Locations
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United States, Colorado
Colorado Center for Reproductive Medicine Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Rachel Makloski, RN       rmakloski@colocrm.com   
Sponsors and Collaborators
Colorado Center for Reproductive Medicine
Investigators
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Principal Investigator: Mandy Katz-Jaffe, PhD Colorado Center for Reproductive Medicine

Additional Information:

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Responsible Party: Mandy Katz-Jaffe, PhD, Research Director, Colorado Center for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT03717441    
Other Study ID Numbers: 2018154
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female