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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Patient Engagement; Patient Satisfaction; IVF; Patient Empowerment
• Intervention / Treatment: Behavioral: CALM IVF; Other: Standard of Care

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: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Standard of care in vitro fertilization patients randomized to the psychoeducational group 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: Control; Standard of care in vitro fertilization patients at our institution.	Other: Standard of Care; 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	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	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	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	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	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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Rachel Whynott
• Investigators: Principal Investigator: Rachel M Whynott, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2019
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: IVF; Stress; Relaxation; Therapy; Support; Education; In vitro fertilization; Knowledge; Group; Relationships
• Other Study ID Numbers: 201906788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No