DNA Analysis of Discarded Media Drops From the Clinical I... | NCT03717441

Studies
DNA Analysis of Discarded Media Drops From the Clinical IVF Cycles

NCT03717441

Sponsor

Colorado Center for Reproductive Medicine

Status

Unknown status

Last Update Posted

Feb 29, 2024Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Infertility

Interventions

chromosome numeration of embryos

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2018Actual

Primary Completion Date

Dec 15, 2025Estimated

Completion Date

Jun 15, 2026Estimated

First Submitted Date

Oct 22, 2018

First Submission Date that Met QC Criteria

Oct 22, 2018

First Posted Date

Oct 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2024

Last Update Posted Date

Feb 29, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mandy Katz-Jaffe, PhD, Research Director, Colorado Center for Reproductive MedicinePrincipal Investigator

Lead Sponsor

Colorado Center for Reproductive MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chromosome numeration of embryos	Diagnostic Test	Use genomic technologies to analyze the discarded media drop for chromosome counting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DNA Analysis of discarded media drops form the clinical IVF Cycles	Analyze media drop for presence of DNA to obtain embryo chromosome numeration	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Recruiting women undergoing In Vitro Fertilization with Comprehensive Chromosomal Screening of embryos

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rachel Makloski	Contact	303-788-8300	1769	rmakloski@colocrm.com

Overall Officials

Name	Affiliation	Role
Mandy Katz-Jaffe, PhD	Colorado Center for Reproductive Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Colorado Center for Reproductive Medicine	Recruiting	Lone Tree	Colorado	80124	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided