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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04048772
Other study ID # 201906788
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 9, 2019
Est. completion date August 2021

Study information

Verified date June 2021
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 141
Est. completion date August 2021
Est. primary completion date August 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

Behavioral:
CALM IVF
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:
Standard of Care
Patients will receive the standard of care IVF treatment at the University of Iowa.

Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Rachel Whynott

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in female fertility patient quality of life score during IVF treatment cycle 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 Change in female GAD-7 score during IVF treatment cycle 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
Secondary Change in female PHQ-9 score during IVF treatment cycle 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
Secondary Change in female Connor-Davidson Resilience Scale during IVF treatment cycle 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
Secondary Change in female knowledge assessment during IVF treatment cycle 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
Secondary Likelihood of continued IVF treatment in the instance of a negative pregnancy test 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
Secondary Change in male fertility patient quality of life score during IVF treatment cycle 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 Change in male GAD-7 score during IVF treatment cycle 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
Secondary Change in male PHQ-9 score during IVF treatment cycle 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
Secondary Change in male Connor-Davidson Resilience Scale during IVF treatment cycle 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
Secondary Change in male knowledge assessment during IVF treatment cycle 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
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