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

NCT04048772 | Unknown

• 1 other identifier: 201906788
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Relaxation; Education; Support; Group; Knowledge; Therapy; In vitro fertilization; Stress; Relationships; IVF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in female GAD-7 score during IVF treatment cycle

  From enrollment to 2-4 days after oocyte retrieval

• Change in female PHQ-9 score during IVF treatment cycle

  From enrollment to 2-4 days after oocyte retrieval

• Change in female Connor-Davidson Resilience Scale during IVF treatment cycle

  From enrollment to 2-4 days after oocyte retrieval

• Change in female knowledge assessment during IVF treatment cycle

  From enrollment to 2-4 days after oocyte retrieval

• Likelihood of continued IVF treatment in the instance of a negative pregnancy test

  Three months after embryo transfer

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: CALM IVF

Control

OTHER

Standard of care in vitro fertilization patients at our institution.

Other: Standard of Care

Interventions

CALM IVF 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.

Intervention

Standard of Care OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients starting their first in vitro fertilization cycle at the University of Iowa Hospitals and Clinics

You may not qualify if:

• 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

Sponsors & Collaborators

• Rachel Whynott: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 36959953 DERIVED

MeSH Terms

Conditions

Patient Satisfaction; Patient Participation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Acceptance of Health Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rachel M Whynott, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fellow Physician

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 7, 2019
• Study Start: August 9, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)