CALM IVF (Creating Affiliations, Learning, and Mindfulness for In Vitro Fertilization Patients)

Quality of Life Clinical Trial

Official title:

Creating Affiliations, Learning, and Mindfulness for In Vitro Fertilization Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04048772
• Other study ID #: 201906788
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• IVF
• Patient Empowerment
• Patient Engagement
• Patient Satisfaction
• Quality of Life

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