Clinical trial NCT03383848: Evaluation of Patient Experience and Quality of Life During In Vitro Fertilization Treatment
Official title: Evaluation of Patient Experience and Quality of Life During In Vitro Fertilization Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Documented Medication Errors
timeFrame: End of treatment cycle, between day 9 and day 15
Secondary outcomes:
measure: Number of Phone and Patient Portal Messages to Infertility Nurses
timeFrame: End of treatment cycle, between day 9 and day 15
measure: Quantity of Medication Waste
timeFrame: End of treatment cycle, between day 9 and day 15
measure: Stress Level
timeFrame: Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)
measure: Anxiety Level
timeFrame: Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)
measure: Quality of Life
timeFrame: Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Center for Reproductive Medicine, University of Michigan
state: Michigan
city: Northville
country: United States
facility: Northville Health Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michael Lanham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.