Evaluation of Patient Experience and Quality of Life During In Vitro Fertilization Treatment



Status:Recruiting
Conditions:Women's Studies, Infertility
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:12/26/2018
Start Date:January 10, 2018
End Date:June 30, 2019
Contact:Sarah M Block
Email:smblock@med.umich.edu
Phone:734-998-0531

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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.

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.

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
We found this trial at
2
sites
39901 Traditions Drive
Northville, Michigan 48168
Principal Investigator: Michael Lanham, MD
Phone: 734-998-0531
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Ann Arbor, Michigan 48108
Principal Investigator: Michael Lanham, MD
Phone: 734-998-0531
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials