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

NCT04048772 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2021-06-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Rachel Whynott

    lead OTHER

Principal Investigators

  • Rachel M Whynott, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-09
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04048772 on ClinicalTrials.gov