- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048772
CALM IVF (Creating Affiliations, Learning, and Mindfulness for In Vitro Fertilization Patients)
Creating Affiliations, Learning, and Mindfulness for In Vitro Fertilization Patients
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Standard of care in vitro fertilization patients randomized to the psychoeducational group intervention.
|
The intervention will be three 1-1.5 hour interactive sessions that are scheduled throughout the participant's first in vitro fertilization 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.
|
Other: Control
Standard of care in vitro fertilization patients at our institution.
|
Patients will receive the standard of care IVF treatment at the University of Iowa.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in female fertility patient quality of life score during IVF treatment cycle
Time Frame: From enrollment to 2-4 days after oocyte retrieval
|
FertiQoL International (Fertility Quality of Life Questionnaire 2008), scored scale from 0-100, with higher values indicating a higher quality of life and low scores indicating a lower quality of life.
|
From enrollment to 2-4 days after oocyte retrieval
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in female GAD-7 score during IVF treatment cycle
Time Frame: From enrollment to 2-4 days after oocyte retrieval
|
Generalized Anxiety Disorder 7-item scale, with higher scores indicating higher likelihood of an anxiety disorder and lower scores indicating less likelihood of an anxiety disorder.
|
From enrollment to 2-4 days after oocyte retrieval
|
Change in female PHQ-9 score during IVF treatment cycle
Time Frame: From enrollment to 2-4 days after oocyte retrieval
|
Patient Health Questionnaire, with higher score indicating increased likelihood of a depressive disorder and lower scores indicating less likelihood of a depressive disorder.
|
From enrollment to 2-4 days after oocyte retrieval
|
Change in female Connor-Davidson Resilience Scale during IVF treatment cycle
Time Frame: From enrollment to 2-4 days after oocyte retrieval
|
Connor-Davidson Resilience Scale, with higher scores indicating greater resilience, and lower scores indicating lower resilience
|
From enrollment to 2-4 days after oocyte retrieval
|
Change in female knowledge assessment during IVF treatment cycle
Time Frame: From enrollment to 2-4 days after oocyte retrieval
|
Assessment of knowledge regarding IVF treatment, with higher scores indicating a greater knowledge of IVF treatment, and lower scores indicating less knowledge regarding IVF treatment
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From enrollment to 2-4 days after oocyte retrieval
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Likelihood of continued IVF treatment in the instance of a negative pregnancy test
Time Frame: Three months after embryo transfer
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Patients who are not pregnant after embryo transfer will be followed for three months to assess likelihood to return for additional treatment after negative embryo transfer outcome.
|
Three months after embryo transfer
|
Change in male fertility patient quality of life score during IVF treatment cycle
Time Frame: From enrollment to 2-4 days after oocyte retrieval
|
FertiQoL International (Fertility Quality of Life Questionnaire 2008), scored scale from 0-100, with higher values indicating a higher quality of life and low scores indicating a lower quality of life.
|
From enrollment to 2-4 days after oocyte retrieval
|
Change in male GAD-7 score during IVF treatment cycle
Time Frame: From enrollment to 2-4 days after oocyte retrieval
|
Generalized Anxiety Disorder 7-item scale, with higher scores indicating higher likelihood of an anxiety disorder and lower scores indicating less likelihood of an anxiety disorder.
|
From enrollment to 2-4 days after oocyte retrieval
|
Change in male PHQ-9 score during IVF treatment cycle
Time Frame: From enrollment to 2-4 days after oocyte retrieval
|
Patient Health Questionnaire, with higher score indicating increased likelihood of a depressive disorder and lower scores indicating less likelihood of a depressive disorder.
|
From enrollment to 2-4 days after oocyte retrieval
|
Change in male Connor-Davidson Resilience Scale during IVF treatment cycle
Time Frame: From enrollment to 2-4 days after oocyte retrieval
|
Connor-Davidson Resilience Scale, with higher scores indicating greater resilience, and lower scores indicating lower resilience
|
From enrollment to 2-4 days after oocyte retrieval
|
Change in male knowledge assessment during IVF treatment cycle
Time Frame: From enrollment to 2-4 days after oocyte retrieval
|
Assessment of knowledge regarding IVF treatment, with higher scores indicating a greater knowledge of IVF treatment, and lower scores indicating less knowledge regarding IVF treatment
|
From enrollment to 2-4 days after oocyte retrieval
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rachel M Whynott, MD, University of Iowa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 201906788
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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