NCT03717441

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Oct 2018Jun 2026

First Submitted

Initial submission to the registry

October 22, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Expected
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

7.2 years

First QC Date

October 22, 2018

Last Update Submit

February 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Use genomic technologies to analyze the discarded media drop for chromosome counting

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, 80124, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Media drops form IVF cycle

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mandy Katz-Jaffe, PhD

    Colorado Center for Reproductive Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Makloski

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Research Director

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

October 22, 2018

Primary Completion

December 15, 2025

Study Completion (Estimated)

June 15, 2026

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations