Clinical trial NCT04048772: CALM IVF (Creating Affiliations, Learning, and Mindfulness for In Vitro Fertilization Patients)
Official title: Creating Affiliations, Learning, and Mindfulness for In Vitro Fertilization Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
IVF
Patient Satisfaction
Patient Engagement
Patient Empowerment
Keywords: Relaxation
Education
Support
Group
Knowledge
Therapy
In vitro fertilization
Stress
Relationships
IVF
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Patients and their partners will be randomized in a 2:1 fashion to two different treatment arms: A) standard of care in vitro fertilization (IVF) at the investigational institution as well as participating in an additional psychoeducational group or B) standard of care IVF at the investigational institution. The intervention group will consist of three additional evening visits for 1-1.5 hours per session. The sessions will include an interactive educational component addressing usual questions and concerns of IVF patients, such as reviewing common IVF myths, and also more information regarding treatment and technologies. Each session will also include teaching of coping strategies (such as awaiting the pregnancy test, how to cope with insensitive remarks from friends and family) as well as relaxation exercises, such as progressive muscle relaxation and deep breathing.

The patients will be consented at their new IVF visit and will take their initial assessments (FertiQoL, GAD-7, PHQ-9, the Connor-Davidson Resilience Scale, and a knowledge assessment) within 24 hours of the new visit. The patients will be assigned into groups based on when they are going through their IVF stimulations, so they will have similar experiences at similar times. Patients will take their final assessments on the third day after egg retrieval, regardless of group assignment.

Eligibility criteria: Inclusion Criteria:

* All patients starting their first in vitro fertilization cycle at the University of Iowa Hospitals and Clinics

Exclusion Criteria:

* Patients who have already undergone in vitro fertilization treatment at any institution
* Non-English speakers
* Fertility preservation patients
* Patients using donor oocytes, embryos, or sperm
* Patients taking psychotropic medications for depression or anxiety that have had a dosing adjustment within 3 months of study enrollment

Primary outcomes:
measure: Change in female fertility patient quality of life score during IVF treatment cycle
timeFrame: From enrollment to 2-4 days after oocyte retrieval
Secondary outcomes:
measure: Change in female GAD-7 score during IVF treatment cycle
timeFrame: From enrollment to 2-4 days after oocyte retrieval
measure: Change in female PHQ-9 score during IVF treatment cycle
timeFrame: From enrollment to 2-4 days after oocyte retrieval
measure: Change in female Connor-Davidson Resilience Scale during IVF treatment cycle
timeFrame: From enrollment to 2-4 days after oocyte retrieval
measure: Change in female knowledge assessment during IVF treatment cycle
timeFrame: From enrollment to 2-4 days after oocyte retrieval
measure: Likelihood of continued IVF treatment in the instance of a negative pregnancy test
timeFrame: Three months after embryo transfer
measure: Change in male fertility patient quality of life score during IVF treatment cycle
timeFrame: From enrollment to 2-4 days after oocyte retrieval
measure: Change in male GAD-7 score during IVF treatment cycle
timeFrame: From enrollment to 2-4 days after oocyte retrieval
measure: Change in male PHQ-9 score during IVF treatment cycle
timeFrame: From enrollment to 2-4 days after oocyte retrieval
measure: Change in male Connor-Davidson Resilience Scale during IVF treatment cycle
timeFrame: From enrollment to 2-4 days after oocyte retrieval
measure: Change in male knowledge assessment during IVF treatment cycle
timeFrame: From enrollment to 2-4 days after oocyte retrieval
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Rachel M Whynott, MD
role: PRINCIPAL_INVESTIGATOR
References: