InfertilityNCT03383848
Evaluation of Patient Experience and Quality of Life During In Vitro Fertilization Treatment
A study testing Medication Management Software in people with Infertility, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Medication Management Software
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2018to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Reproductive Medicine, University of Michigan
Ann Arbor, Michigan, 48108
Northville Health Center
Northville, Michigan, 48168
About this study
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.
Read the detailed description
In the United States, individuals suffering from infertility pursued approximately 190,000 cycles of in vitro fertilization (IVF) in 2014, with approximately 1.5 million cycles performed internationally. Without insurance coverage, each cycle can cost between $15,000 and $25,000 for medications and procedures. The goal of an IVF cycle is a healthy baby, but to achieve this goal, patients and their partners are asked to manage administration and inventory of between 6 and 12 medications with doses and routes that can change daily. Due to the complexity of the treatment and the fact that the medications are expensive and ordered by patients incrementally to reduce large amounts of waste, medication errors (wrong dose; missed dose; running out of medication) are common (3-15% of patients).
The current standard is that patients manage this process of medication inventory, administration, and refills on their own with their own systems, using paper calendars provided by a clinic (which are immediately inaccurate once the cycle starts), paper-and-pencil lists, electronic lists, or generic medication-tracking applications, combined with verbal and written reminders from their clinic. Not having the right medication at the right time is the most critical error, and with the current methods, the patient often does not realize this fact while there is sufficient time to rectify the inventory problem, and the clinic has no way to catch at-risk patients proactively. For these patients, this error can mean a sub-optimal response with a lower chance of pregnancy that particular month (as low as 0%, depending on the error). Of the patients undergoing IVF with perfect adherence, only about 50% achieve the goal of a healthy baby. For the remainder, there will always be the concern that perhaps they could have had a different outcome, and for those with a medication error, they will never know whether the outcome could have been different if that error had not occurred.
This study will determine if patients using medication management software will have lower numbers of documented medication errors (as captured through the software and/or reported by the patient to the clinical team caring for them during their IVF cycle) compared to patients who use standard paper/pencil or home-grown methods to track their medication inventory.
- Conditions
- Infertility
- Being tested
- Medication Management Software
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of treatment cycle, between day 9 and day 15
Secondary outcomes (5)
Number of Phone and Patient Portal Messages to Infertility Nurses
Number of phone and patient portal (electronic health record) messages to infertility nurses from patients using the software as compared to those using standard pencil/paper or homegrown methods to track medication inventory.
Measured: End of treatment cycle, between day 9 and day 15
Quantity of Medication Waste
Amount of medication patient has left at the end of the IVF cycle, as an indication of medication tracking errors.
Measured: End of treatment cycle, between day 9 and day 15
Stress Level
Change in stress levels as measured by CART (Concerns of Women Undergoing Assisted Reproductive Technologies) survey.
Measured: 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
Change in state anxiety score as measured by Spielberger's State-Trait Anxiety Inventory survey.
Measured: 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
Change in quality of life assessment as measured by FertiQoL (Fertility Patient Quality of Life) questionnaire.
Measured: Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start10 Jan 2018
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Lanham, University of Michigan
- Investigators
- Michael Lanham, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383848
- Sponsor's protocol ID
- HUM00121481
- Status last verified
- Dec 2020
- First submitted
- 19 Dec 2017
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34016436
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Experience and Quality of Life During In Vitro Fertilization Treatment
- ClinicalTrials.gov ID
- NCT03383848
- Acronym / sponsor ID
- HUM00121481
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the United States, individuals suffering from infertility pursued approximately 190,000 cycles of in vitro fertilization (IVF) in 2014, with approximately 1.5 million cycles performed internationally. Without insurance coverage, each cycle can cost between $15,000 and $25,000 for medications and procedures. The goal of an IVF cycle is a healthy baby, but to achieve this goal, patients and their partners are asked to manage administration and inventory of between 6 and 12 medications with doses and routes that can change daily. Due to the complexity of the treatment and the fact that the medications are expensive and ordered by patients incrementally to reduce large amounts of waste, medication errors (wrong dose; missed dose; running out of medication) are common (3-15% of patients).
The current standard is that patients manage this process of medication inventory, administration, and refills on their own with their own systems, using paper calendars provided by a clinic (which are immediately inaccurate once the cycle starts), paper-and-pencil lists, electronic lists, or generic medication-tracking applications, combined with verbal and written reminders from their clinic. Not having the right medication at the right time is the most critical error, and with the current methods, the patient often does not realize this fact while there is sufficient time to rectify the inventory problem, and the clinic has no way to catch at-risk patients proactively. For these patients, this error can mean a sub-optimal response with a lower chance of pregnancy that particular month (as low as 0%, depending on the error). Of the patients undergoing IVF with perfect adherence, only about 50% achieve the goal of a healthy baby. For the remainder, there will always be the concern that perhaps they could have had a different outcome, and for those with a medication error, they will never know whether the outcome could have been different if that error had not occurred.
This study will determine if patients using medication management software will have lower numbers of documented medication errors (as captured through the software and/or reported by the patient to the clinical team caring for them during their IVF cycle) compared to patients who use standard paper/pencil or home-grown methods to track their medication inventory.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Software Group | Experimental | Device: Medication Management SoftwareSubjects 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Management SoftwareThe 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. | Device | Experimental Software Group |
Primary outcome
Documented Medication Errors
Time frame: End of treatment cycle, between day 9 and day 15
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.
5 secondary outcomes
Number of Phone and Patient Portal Messages to Infertility Nurses
Time frame: End of treatment cycle, between day 9 and day 15
Quantity of Medication Waste
Time frame: End of treatment cycle, between day 9 and day 15
Stress Level
Time frame: 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
Time frame: 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
Time frame: Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 34016436Martin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lanham, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Management Software in people with Infertility, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documented Medication Errors (time frame: End of treatment cycle, between day 9 and day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03383848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.