NCT03383848

Brief Summary

This study will evaluate if an electronic medication management software solution can improve outcomes for patients undergoing in vitro fertilization (IVF) treatment. Participants will be randomized equally into two groups: half will use the management software, while the other half will act as a control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

2.8 years

First QC Date

December 19, 2017

Last Update Submit

December 14, 2020

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Documented Medication Errors

    Common medication errors such as wrong dose, missed dose, or running out of medication, as captured through the software and/or reported by the patient to the clinical team caring for them during their IVF cycle.

    End of treatment cycle, between day 9 and day 15

Secondary Outcomes (5)

  • Number of Phone and Patient Portal Messages to Infertility Nurses

    End of treatment cycle, between day 9 and day 15

  • Quantity of Medication Waste

    End of treatment cycle, between day 9 and day 15

  • Stress Level

    Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)

  • Anxiety Level

    Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)

  • Quality of Life

    Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)

Study Arms (2)

Experimental Software Group

EXPERIMENTAL

Subjects in the experimental group will be provided with free access to the medication management software online, which will be able to be accessed on the SmartPhone/SmartDevice and home tablet(s) or computer(s) of their choice, through any browser. They will also be provided with links to the surveys to be filled out in the REDCap secure web application throughout the study.

Device: Medication Management Software

Control Group

NO INTERVENTION

Subjects in the control group will receive standard of care, and will receive emails with links to the surveys to be filled out in the REDCap secure web application throughout the study.

Interventions

Medication Management SoftwareDEVICE

The OnTrack Medication Management Software allows patients to track the amount of fertility medication they have at home. When they check off their "to do" list of medications, it decrements the amount they have at home. It allows them to see when they will run out of medication depending on their current doses (which can change daily). Daily use of the software will be 5-10 minutes daily for approximately 21 days.

Experimental Software Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women undergoing IVF cycle (planning egg retrieval) at University of Michigan, for any indication (infertility, fertility preservation, or genetic disorder planning preimplantation genetic screening or diagnosis)
  • English as primary language
  • Owns a smartphone
  • Owns a non-smartphone device with access to the internet at home (tablet, laptop computer, or desktop computer)
  • Has internet access at home

You may not qualify if:

  • Non-English speaker as primary language
  • Previous participant in same study
  • Not undergoing IVF fertility treatment
  • Does not own a smartphone
  • Does not own a tablet, laptop computer, or desktop computer
  • Does not have internet access at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Reproductive Medicine, University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Northville Health Center

Northville, Michigan, 48168, United States

Location

Related Publications (1)

  • Martin CE, Lanham M, Almgren-Bell A, Marsh C, Omurtag K. A randomized controlled trial to evaluate the use of a web-based application to manage medications during in vitro fertilization. Fertil Steril. 2021 Sep;116(3):793-800. doi: 10.1016/j.fertnstert.2021.04.022. Epub 2021 May 18.

    PMID: 34016436DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Michael Lanham, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

January 10, 2018

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)