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Intervention for Patient Engagement

N/A
Waitlist Available
Led By Rachel M Whynott, MD
Research Sponsored by Rachel Whynott
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients starting their first in vitro fertilization cycle at the University of Iowa Hospitals and Clinics
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 2-4 days after oocyte retrieval
Awards & highlights
No Placebo-Only Group

Study Summary

The investigators have designed a psychoeducational group curriculum specifically for new in vitro fertilization (IVF) patients (both male and female) to improve their treatment knowledge, to allow them to engage more in their care, to offer a support network, to improve satisfaction, and to provide them with tools to help reduce their stress and anxiety while undergoing the IVF process. The investigators plan to have four to eight infertility patients and their partners participate in a group at a time, for which they will attend three 1-1.5 hour interactive sessions that are scheduled throughout their first IVF cycle. These sessions will provide additional time for discussion about treatment with providers, learning opportunities on topics of interest to fertility patients, and stress reduction techniques. They will do several surveys before and after the intervention for comparison, including assessment of quality of life, depression, anxiety, resilience, and a knowledge assessment. The investigators will also track the patients to see if they pursue additional treatment in the instance of a negative pregnancy test compared to patients undergoing the standard treatment. The investigators plan to recruit a control group that receives the standard of care treatment here at the University of Iowa.

Eligible Conditions
  • Patient Engagement
  • Quality of Life
  • In Vitro Fertilization
  • Patient Empowerment
  • Patient Satisfaction

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 2-4 days after oocyte retrieval
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 2-4 days after oocyte retrieval for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in female fertility patient quality of life score during IVF treatment cycle
Secondary outcome measures
Change in female Connor-Davidson Resilience Scale during IVF treatment cycle
Change in female GAD-7 score during IVF treatment cycle
Change in female PHQ-9 score during IVF treatment cycle
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Standard of care in vitro fertilization patients randomized to the psychoeducational group intervention.
Group II: ControlExperimental Treatment1 Intervention
Standard of care in vitro fertilization patients at our institution.

Find a Location

Who is running the clinical trial?

Rachel WhynottLead Sponsor
Rachel M Whynott, MDPrincipal InvestigatorUniversity of Iowa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Minnesota
California
Texas
Other
How old are they?
18 - 65
What site did they apply to?
University of Iowa Hospitals and Clinics
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
~26 spots leftby Feb 2025