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

NCT ID: NCT04048772

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-09
• Study Completion Date: 2021-08-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

Standard of care in vitro fertilization patients randomized to the psychoeducational group intervention.

Group Type: EXPERIMENTAL

CALM IVF

Intervention Type: BEHAVIORAL

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.

Control

Standard of care in vitro fertilization patients at our institution.

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

Patients will receive the standard of care IVF treatment at the University of Iowa.

Interventions

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.

Intervention Type: BEHAVIORAL

Standard of Care

Patients will receive the standard of care IVF treatment at the University of Iowa.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rachel Whynott

OTHER

Sponsor Role: lead

Responsible Party

Rachel Whynott

Fellow Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rachel M Whynott, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

References

Whynott RM, Summers KM, Mejia RB, Segre LS, Ryan G, Pawlak SA. Creating affiliations, learning, and mindfulness for in vitro fertilization patients (CALM IVF): a clinical trial. F S Rep. 2023 Jan 7;4(1):61-71. doi: 10.1016/j.xfre.2023.01.002. eCollection 2023 Mar.

Reference Type: DERIVED

PMID: 36959953 (View on PubMed)

Other Identifiers

201906788

Identifier Type: -

Identifier Source: org_study_id